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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 Taw, Jack, .
Stanford Investigators
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Phase III APR-246 + Azacitidine vs Azacitidine Alone in TP53 Mutant Myelodysplastic Syndromes
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A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
Stanford is currently not accepting patients for this trial.
For more information, please contact Taw, Jack, .
Stanford Investigators
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Survival Data Collection In Subjects Previously Enrolled In Celgene PROT CC-5013-MDS-0003
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Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1 MDS Patients
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Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox.
Deferasirox were administered orally once per day for 12 months.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
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This randomized phase II trial studies azacitidine with or without entinostat to see how well they work compared to azacitidine alone in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, 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. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may work better in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mai Tran, .
Stanford Investigators
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Phase II Azacitidine +/- Lenalidomide or Vorinostat in Higher-Risk MDS or CMML
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This randomized phase II/III trial studies how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Medeiros, Bruno, C, .
Stanford Investigators
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Phase III Roxadustat (FG-4592) in Tx of Anemia in Low Risk MDS w/ Low RBC Transfusion Burden
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The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jones, Robert, P., .
Stanford Investigators
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Phase IIIB Rollover Evaluation of Long-Term Safety in Participants in other Luspatercept(ACE-536) CT
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A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:
* Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept
* Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met
* The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase
* Transition Phase is defined as one Enrollment visit
* Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol
* Follow-up Phase includes:
- 42 Day Safety Follow-up Visit
* During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting
- Long-term Post-treatment Follow-up (LTPTFU) Phase
* Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule
Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.
The ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.
Stanford is currently not accepting patients for this trial.
For more information, please contact Taw, Jack, .
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 Greenberg, Peter, L, .
Stanford Investigators
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Phase II Rigosertib in MDS
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The study will enroll low risk MDS patients who need red blood cell transfusions and who are refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is to determine whether oral rigosertib treatment results in hematological improvements according to the 2006 International Working Group criteria in these patients. The study will also record any side effects that may occur during the study.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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DARBEPOETIN ALFA in MDS
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The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Biologically Focused Therapy of Treatment-Refractory MDS Patients
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This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jones, Robert, P., .
Lead Sponsor
Stanford Investigators
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Phase II Study of GX15-070MS for previously untreated MDS w/Anemia and/or Thrombocytopenia
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Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Phase I/II Anti-EphA3 Monoclonal Antibody KB004 in EphA3-Expressing Hematologic Malignancies
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This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Bevacizumab in Treating Patients With Myelodysplastic Syndrome
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RATIONALE: Monoclonal antibodies, such as bevacizumab, 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 deliver cancer-killing substances to them.
PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
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Phase IIIB Rigosertib IV in Myelodysplastic Syndrome with Excess Blasts
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This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
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The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mai Tran, .
Stanford Investigators
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Phase II Azacitidine +/- Birinapant in Higher Risk MDS / CML
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This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and mechanistic studies support that azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes
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This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10\^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Biologic Correlates for "Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy/Intermed-2/High Risk"
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This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Phase I/II Eltrombopag in Thrombocytopenic Subjects with Advanced MDS or Secondary AML after MDS
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This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Study Comparing DACOGEN® for Injection and VIDAZA® for Injection In Subjects with MDS
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The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Phase II Eltrombopag in Thrombocytopenic w/ Myelodysplastic Syndromes or Acute Myeloid Leukemia
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This was a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy. This objective was assessed by a composite primary endpoint that consists of the following: the proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts \<10 Gi/L, or platelet transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy were enrolled in the study. No low or intermediate-1 risk MDS subjects were enrolled in the study. Subjects must have had at least one of the following during the 4 weeks prior to enrolment: platelet count \<10 Gi/L, platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC), including hydroxyurea, was allowed as indicated by local practice throughout the study. The study had 3 sequential parts. Subjects who were enrolled in Part 1 (open-label) cannot be enrolled in Part 2 of the study (randomized, double-blind); however, subjects who completed the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) continued in Part 3 (extension) if the investigator determined that the subject was receiving clinical benefit on treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Tipifarnib in Treating Patients With Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or Undifferentiated Myeloproliferative Disorders
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This phase 1-2 trial studies the side effects and how well tipifarnib works in treating patients with chronic myeloid leukemia, chronic myelomonocytic leukemia, or undifferentiated myeloproliferative disorders. Tipifarnib may stop the growth of cancer 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 Richard Renn, .
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 Greenberg, Peter, L, .
Stanford Investigators
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Phase Ib Atezolzumab (MPD3280A, Anti-PD-L1 Antibody) +/- Azacitidine in Myelodysplastic Syndromes
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This is a multicenter, open-label, Phase 1b study of atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] monoclonal antibody) in participants who have hypomethylating agent (HMA)-naïve myelodysplastic syndromes (MDS) and are International Prognostic Scoring System-Revised (IPSS-R) intermediate/high/very high-risk, or have MDS relapsed or are refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine the safety and tolerability of atezolizumab therapy in these participant populations, including treatment in combination with azacitidine.
Stanford is currently not accepting patients for this trial.
For more information, please contact Taw, Jack, .
Stanford Investigators
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Phase I Splicing Modulator H3B-8800 in MDS, AML, and CML
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A Phase 1, an Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 (RVT-2001) for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
Stanford is currently not accepting patients for this trial.
For more information, please contact Taw, Jack, .
Stanford Investigators
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(QUANTUM-WILD) (QUIZARTINIB OR PLACEBO PLUS CHEMOTHERAPY IN NEWLY DIAGNOSED PATIENTS WITH FLT3-ITD N
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This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Stanford Investigators
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Phase III Deferasirox (Exjade) in MDS (low/int-1 risk) and Transfusional Iron Overload (TELESTO)
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This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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Phase III Magrolimab in Combo w/ Azacitidine vs Azacitidine +Placebo in Treatment-Naive HighRisk MDS
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The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).
Stanford is currently not accepting patients for this trial.
For more information, please contact Taw, Jack, .
Stanford Investigators
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Phase 1b Open Label Dose Optimization & Expansion of DFV890 in Adult Patients w/ Myeloid Diseases
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Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).
Stanford is currently not accepting patients for this trial.
For more information, please contact Taw, Jack, 650-723-4000.
Stanford Investigators
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Phase III Comparing MER to Tx with Lenalidomide +/- Epoetin Alfa for Low/Intermed Risk MDS
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This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Greenberg, Peter, L, .
Stanford Investigators
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