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Phase II Prospective Evaluation of Ruxolitinib Efficacy for CNL/aCML Patients with Mutation of CSF3R
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This phase II trial studies how well ruxolitinib phosphate works in treating patients with chronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cells to reproduce. This trial also studies the genetic makeup of patients. Certain genes in cancer cells may determine how the cancer grows or spreads and how it may respond to different drugs. Studying how the genes associated with CNL and aCML respond to the study drug may help doctors learn more about CNL and aCML and improve the treatment for these diseases.
Stanford is currently not accepting patients for this trial.
For more information, please contact Isabel Reyes, 650-725-4047.
Stanford Investigators
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Phase III Bomedemstat(MK-3543/IMG-7289) vs Best Available Therapy (BAT) in Essential Thrombocythemia
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This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
Stanford Investigators
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Phase II/III KRT-232 in PMF, Post-PV-MF or Post-ET-MF who're Relapsed/Refractory to JAK Inhibitor Tx
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This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.
Stanford is currently not accepting patients for this trial.
For more information, please contact Justin Abuel, 6507231367.
Stanford Investigators
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Pilot Lenalidomide in Adult Diamond-Blackfan Anemia Patients w/ RBC Transfusion-Dependent Anemia
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This is a single-center, single arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion dependent adult subjects with Diamond-Blackfan Anemia (DBA).
Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood cell transfusion independence \[MDS International Working Group (IWG) 2000 Criteria will be applied\].
Secondary Objective: 1)To evaluate the tolerability and safety profile of lenalidomide in patients with DBA and other inherited marrow failure syndromes 2) To correlate response to lenalidomide with biologic surrogates of DBA including ribosomal protein mutation status, ex vivo erythroid colony growth, and microarray gene expression
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 650-725-4047.
Stanford Investigators
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Phase Ib Idelalisib&Ruxolitinib as Tx in PMF /Post-PV MF /Post-ET MF w/Progressive /Relapsed Disease
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The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease.
This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).
Stanford is currently not accepting patients for this trial.
For more information, please contact Isabel Reyes, 650-725-4047.
Stanford Investigators
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Phase II ON 01910.Na for Intermediate1-2, or High Risk Trisomy 8 MDS
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This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients with Trisomy 8 or classified as Intermediate-1, -2 or High Risk who are not responding to current therapeutic options. The rationale for this trial is based upon data from laboratory studies with ON 01910.Na and upon activity that has been observed in other clinical trials with ON 01910.Na in patients with MDS.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Phase III Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera
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The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III PEGASYS vs Hydroxyurea in High Risk Polycythemia Vera or Essential Thrombocythemia
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This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increases the risk of developing blood clots.
The purpose of this study is to look at the effectiveness of giving participants who have been diagnosed with ET or PV one of two different study regimens over time. The study subject will be followed for their condition for about 5 years. The subject will be randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already receiving treatment for either PV or ET. Each of the study drugs used in this study is already being used to treat subjects with ET or PV currently, but the investigators are unsure which study drug is better.
Stanford is currently not accepting patients for this trial.
For more information, please contact Isabel Reyes, 650-725-4047.
Stanford Investigators
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Extended Tx in Subjects Continuing to Benefit from Ibrutinib After Completion of Ibrutinib CT
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Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I BLU-285 in Advanced Systemic Mastocytosis (advSM) &Relapsed /Refractory Myeloid Malignancies
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This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (also known as BLU-285), administered orally (PO), in adult patients with advanced systemic mastocytosis and other relapsed or refractory myeloid malignancies. The study consists of 2 parts:, dose-escalation (Part 1) and expansion (Part 2).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II PKC412 in Aggressive Systemic Mastocytosis and Mast Cell Leukemia
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The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be evaluated on the basis of response rate, when administered to patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL)
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Biomarker To Evaluate protein Profiles of neutropnic Fever/Infection with Acute or Chronic Leukemias
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The purpose of this study is to measure, in pilot/observational study, panels of circulating proteins in real time at the onset of neutropenic fever/infection in patients with acute or chronic leukemias undergoing chemotherapy or other biologic treatment. And to generate preliminary trend results in panels of circulating proteins longitudinally during the period of neutropenia and to correlate those values to clinical/laboratory data and patient outcomes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Lead Sponsor
Stanford Investigators
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Phase II Avapritinib (BLU-285) in Indolent & Smoldering Systemic Mastocytosis
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This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Open-Label Study of SAR302503 Long-Term Effects for Primary or Secondary Myelofibrosis
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The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Phase III SAR302503 in Primary/ Post Polycythemia Vera/ Post Essential Thrombocythemia Myelofibrosis
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Primary Objective:
* To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI).
Secondary Objectives:
* To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
* To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
* To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
* To evaluate the durability of splenic response.
* To evaluate the safety of IMP.
Stanford is currently not accepting patients for this trial.
For more information, please contact Harshdeep Kaur, 6507233589.
Stanford Investigators
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Phase II Imetelstat in Intermediate-2 / High-Risk MF Relapsed/Refractory to Janus Kinase Inhibitor
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The purpose of this study is to evaluate the efficacy and safety of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) whose disease is relapsed after or is refractory to Janus Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Hepcidin Mimetic PTG-300 in Phlebotomy-Requiring Polycythemia Vera
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This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II GS-6624 in Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
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This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF).
The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.
Stanford is currently not accepting patients for this trial.
For more information, please contact Harshdeep Kaur, 650-723-3589 .
Stanford Investigators
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Phase II INCB054828 in Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
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The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.
Stanford is currently not accepting patients for this trial.
For more information, please contact Study Coordinator Justin Abuel, 650-723-1367.
Stanford Investigators
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Randomized, Double-Blind, Placebo-Controlled Study of INCB018424 for PMF, PPV-MF or PET-MF
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This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Phase II ABT-199 (GDC-0199) in CLL w/ Relapse or Refractory to BCR Signaling Pathway Inhibitor Tx
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This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Asma Khan, 650-724-6008.
Stanford Investigators
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Phase II Luspatercept (ACE-536) in Myeloproliferative Neoplasm-Associated Myelofibrosis & Anemia +/-
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This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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ExtendedAccess Momelotinib in PMF /Post-polycythemiaVera /Post-EssentialThrombocythemiaMyelofibrosis
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The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Luspatercept (ACE-536) vs Placebo in Anemia Due to IPSS-R Very Low /Low /Intrmdt Risk MDS
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The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Study IPI-926 in Myelofibrosis
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The purpose of this study is to determine the safety and efficacy of IPI-926 in patients with myelofibrosis (MF) (primary myelofibrosis \[PMF\], post-polycythemia vera myelofibrosis \[post-PV MF\], or post-essential thrombocythemia myelofibrosis \[post-ET MF\]).
Stanford is currently not accepting patients for this trial.
For more information, please contact Harshdeep Kaur, 6507233589.
Stanford Investigators
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Phase II Momelotinib PMF, Post-PV Myelofibrosis, Post-ET Myelofibrosis, PV, or ET
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This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 650-725-4047.
Stanford Investigators
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Phase I/II Venetoclax + Ibrutinib in Relapsed or Refractory CLL & Small Lymphocytic Leukemia
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This is an open-label non-randomized two-center phase 2 study evaluating the safety and efficacy of concurrent therapy with ibrutinib and venetoclax in subjects with relapsed or refractory CLL/SLL.
Stanford is currently not accepting patients for this trial.
For more information, please contact Nini Estevez, 650-725-4041.
Stanford Investigators
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Phase I Open-Label Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms
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This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
Stanford Investigators
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Investigation of Dysregulated Signaling in MPD via Multiparameter Phospho-specific Flow Cytometry
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The objective of this study is to better understand the underlying pathogenetic mechanisms of myeloproliferative disorders (MPDs). We will collect peripheral blood samples from MPD patients and utilize multiparameter phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from these patients. This will provide deeper insights into the pathogenesis of MPDs and may lead to the identification of novel targets for therapeutic intervention.
Stanford is currently not accepting patients for this trial.
For more information, please contact Stephen Oh, 650-723-7875.
Lead Sponsor
Stanford Investigators
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Phase I/II SL-401 in Advanced High Risk Myeloproliferative Neoplasms
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This multicenter, multi-arm trial evaluated the safety and efficacy of tagraxofusp, a cell division cycle protein 123 homolog-targeted therapy, in participants with either CMML or MF. There were 2 CMML cohorts, 1 enrolled participant with CMML (CMML-1 or CMML-2) who were refractory/resistant or intolerant to hypomethylating agents (HMA), hydroxyurea (HU), or intensive chemotherapy and 1 enrolled treatment-naive participants with CMML (CMML-1 or CMML-2) with molecular features associated with poor prognosis. The MF cohort enrolled participants who were resistant/refractory or intolerant to approved Janus kinase (JAK) therapy (JAK1/JAK2 or JAK2).
Stanford is currently not accepting patients for this trial.
For more information, please contact Jason Gotlib, M.D., .
Stanford Investigators
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Phase I/II INCB000928 +/- Ruxolitinib in Participants w/ Anemia Due to Myeloproliferative Disorders
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This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Phase II Study of Ibrutinib in Advanced Systemic Mastocytosis
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This phase 2 trial studies ibrutinib to see how well it works in treating patients with systemic (affecting the entire body) mastocytosis that has spread to other parts of the body and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis is a disease in which too many mast cells (a type of immune system cell) are found throughout the body. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of the enzymes needed for cell growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cristina Daniels, 650-723-0381.
Stanford Investigators
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Phase II PRM-151 In Primary Myelofibrosis (PMF), post-PV MF or post-ET MF
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RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue.
The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.
Stanford is currently not accepting patients for this trial.
For more information, please contact Isabel Reyes, 650-725-4047.
Stanford Investigators
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Phase II CYT387 in Myelofibrosis/Post-Polycythemia Vera/Post-Essential Thrombocythemia Myelofibrosis
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This extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 (momelotinib) will be evaluated.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254027.
Stanford Investigators
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Phase III Obinutuzumab +/- Chlorambucil, ACP-196 +/- Obinutuzumab & ACP-196 Monotherapy in CLL
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This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.
2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)
Stanford is currently not accepting patients for this trial.
For more information, please contact Nini Estevez, 650-725-4041.
Stanford Investigators
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Observational Retrospective Avapritinib Compared w/BestAvailable Tx in AdvancedSystemic Mastocytosis
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BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.
Stanford Investigators
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A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
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This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Bendamustine +Rituximab vs Ibrutinib +Rituximab vs Ibrutinib Alone in CLL
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This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Kevin Morrison, 650-725-5459.
Stanford Investigators
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Phase II Ruxolitinib in Idiopathic Hypereosinophilic Syndrome & Primary Eosinophilic Disorders
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This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
Stanford Investigators
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Phase II Avapritinib (BLU-285) KIT Mutation-targeted TKI in Advanced Systemic Mastocytosis
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This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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PhaseII TL-895 Myelofibrosis JAKi IntolerantMyelofibrosis JAKi TxIneligibleMyelofibrosis orISM
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This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Stanford Investigators
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Phase II Brentuximab Vedotin (SGN-35) in CD30-Positive Systemic Mastocytosis +/- AHNMD
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This pilot clinical trial studies brentuximab vedotin in treating patients with advanced systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
Stanford is currently not accepting patients for this trial.
For more information, please contact Cristina Daniels, 650-723-0381.
Stanford Investigators
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Phase II Pacritinib in Myeloproliferative Disorders Previously Treated with Ruxolitinib
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This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients)
Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis
Intervention/treatment: Drug-Pacritinib
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Ibrutinib Plus Obinutuzumab vs Ibrutinib Plus Venetoclax & Obinutuzumab in CLL
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This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
Stanford is currently not accepting patients for this trial.
For more information, please contact Site Public Contact, 650-498-7061.
Stanford Investigators
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Phase III ON 01910.Na in MDS with Excess Blasts after Relapsed/Refractory/Intolerant to 5-AZC or DAC
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The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
Stanford is currently not accepting patients for this trial.
For more information, please contact Savita Kamble, 6507238594.
Stanford Investigators
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Phase I TG101348 for Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
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The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Phase I/II CYT387 in Primary Myelofibrosis or Post-PV or Post-ET/PV MF
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This study seeks to (i) determine a safe and tolerated dose of CYT387 (momelotinib) given to patients with PMF, post-PV or post-ET and, (ii) assess the effectiveness of orally-administered CYT387 as a treatment for PMF, post-PV or post-ET.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Phase I/II CLT-008 after Post-Remission Therapy for High Risk Leukemia or MDS
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Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Phase III Oral Pacritinib vs Best Available Tx in Thrombocytopenia & PMF /PPVMF /Post-ET MF
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Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.
Stanford is currently not accepting patients for this trial.
For more information, please contact Isabel Reyes, 650-725-4047.
Stanford Investigators
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Phase II Midostaurin in ASM or MCL +/- Associated Hematological Clonal Non-Mast Cell Lineage Disease
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The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrea Linder, 6507254047.
Stanford Investigators
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Phase II CGT9486 as a Single Agent in Advanced Systemic Mastocytosis
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This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Stanford Investigators
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Phase III Momelotinib vs. Ruxolitinib in PMF / Post-PV/ET Myelofibrosis
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This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).
Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cristina Daniels, 650-723-0381.
Stanford Investigators
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