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Kamau SCD (BMT 368) - (GENE TRANSFER)
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This study is a first-in-human, single-arm, open-label Phase I/II study of nula-cel in approximately 15 participants, diagnosed with severe Sickle Cell Disease. The primary objective is to evaluate safety of the treatment in this patient population, as well as preliminary efficacy and pharmacodynamic data.
Stanford Investigators
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Phase I Donor Grafts DerivedFrom Orca-Q w/GVHD Prophylaxis in MA-AlloCHT in Hematologic Malignancies
Recruiting
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This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Stanford Investigators
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CD34-Selected Allogeneic HCT w/Myeloablative Conditioning &CD8+ Memory TCell Infusion in MDS AL &CML
Not Recruiting
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This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie Gaudinez, 650-725-4983.
Stanford Investigators
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Phase II Allogeneic CD8 Memory T-Cells Infusion as Consolidative Tx After HCT in Leukemia & Lymphoma
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This phase 2 trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells, such as CD8+ memory T-cells, may boost this effect and may be an effective treatment to kill any cancer cells that may be left in the body (consolidative therapy).
Stanford is currently not accepting patients for this trial.
For more information, please contact Leah Galvez, 650-725-7951.
Stanford Investigators
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Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
Not Recruiting
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To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
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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Bone Marrow Grafting for Leukemia and Lymphoma
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The purpose of this study is to obtain tissue samples for ongoing studies regarding transplant outcomes and complications.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Lead Sponsor
Stanford Investigators
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Phase II Tabelecleucel in Epstein-BarrVirus-Associated Viremia /Malignancy Who Have No AlternativeTx
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The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
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 Immunostimulatory CpG SD-101 + RT in Recurrent/Progressive Lymphoma after Allogeneic HCT
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For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using cells from a healthy donor represents potentially curative treatment. In these individuals, cure is possible because transplantation of healthy donor immune cells can fight the lymphoma in the patient. The goal of this work is to test a strategy that activates the healthy donor immune cells so that they more effectively fight lymphoma and can result in an increased cure rate for these patients. Our group has previously studied CpG, an immune activating medication, in patients with lymphoma and demonstrated modest anti-tumor responses. We now have a more potent form of CpG which we intend to test to see if it will better activate the donor immune cells and result in shrinkage of tumor throughout the entire body, not just at the injected site.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Phase II Donor Statin Tx for Prevention of Severe Acute GVHD after Myeloablative HCT
Not Recruiting
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This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.
Stanford is currently not accepting patients for this trial.
For more information, please contact Leah Galvez, 650-725-7951.
Stanford Investigators
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Mixed Chimera Allogeneic Transplantation from URD for Multiple Myeloma
Not Recruiting
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The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD
Not Recruiting
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To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients with advanced stage MDS and MPD.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Lead Sponsor
Stanford Investigators
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Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Not Recruiting
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The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie G San Pedro-Salcedo, 650-724-1388.
Stanford Investigators
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Transplantation for Patients with CLL
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To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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Phase I MAGE-A10c796T in Stage IIIb / IV Non-Small Cell Lung Cancer
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This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A\*02:01 and/or HLA-A\*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose escalation trial that will evaluate 3 doses of transduced cells administered after a lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.
When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.
Subjects will be seen frequently by the Study Physician right after receiving their T cells back and up to first 6 months. After that, subjects will be seen every three months. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next 10 years. Subjects who have a confirmed response or clinical benefit ≥4 weeks after the first T-cell infusion and whose tumor continues to express the appropriate antigen target may be eligible for a second infusion. All subjects, completing or withdrawing from the Interventional Phase of the study, will enter a 15-year long-term follow-up phase for observation of delayed adverse events. All subjects will continue to be followed for overall survival during the long-term follow-up 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 FLT3Inhibitor Gilteritinib Maintenance Therapy After Allogeneic Transplant in FLT3/ITD AML
Not Recruiting
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The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year 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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Allo BMT in Advanced Leukemia or High Grade Lymphoma
Not Recruiting
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To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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Phase II Ruxolitinib in Combo w/ Corticosteroids in Steroid-Refractory Acute Graft-vs-Host Disease
Not Recruiting
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The purpose of this study was to assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).
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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Haplo Matched Living Donor Tolerance Induction study (CIRM)
Not Recruiting
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This research study is to determine if donor blood stem cells given after living, related, HLA antigen (Ag) haplotype match or living, unrelated donor kidney transplantation. Minimal HLA antigen matching will include matching of 2 HLA antigens that can be either HLA A, B, and /or DR. This research will change the immune system such that immunosuppressive drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.
Stanford is currently not accepting patients for this trial.
For more information, please contact Asha Shori, CCRP, 650-736-0245.
Stanford Investigators
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Phase III Standard-Dose Combo Chemo or High-Dose Combo Chemo +Stem Cell T-plant in Germ Cell Tumors
Not Recruiting
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This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
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 Primary T Regulatory Cell Tx to Treat Visceral Acute GVHD After HCT
Not Recruiting
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This phase I trial studies the side effects and best dose of donor regulatory T cells in treating patients with graft-versus-host disease affecting the liver or gastrointestinal organs (visceral) within 100 days (acute) after undergoing a stem cell transplant. Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a type of immune cell that may be able to reduce the attack of the donor's immune cells on the patient's normal cells and help treat graft-vs-host disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joanne Otani, 650-721-2372.
Stanford Investigators
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Phase III Axicabtagene Ciloleucel vs SoC Therapy in Relapsed/Refractory Diffuse Large BCell Lymphoma
Not Recruiting
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The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
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 Obinutuzumab in Prevention of cGVHD After Allogeneic Peripheral Blood Stem Cell Transplant
Not Recruiting
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This research study is studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD).
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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Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML
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Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 650-725-1647.
Lead Sponsor
Stanford Investigators
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Allogeneic HCT vs Hypomethylating Tx or Best Supportive Care in High Risk MDS
Not Recruiting
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This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Phase II Novel Approaches for GVHD Prevention Compared to Contemporary Controls
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Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Allogeneic Transplantation Using TLI & ATG for Older Patients with Hematologic Malignancies
Not Recruiting
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To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Lead Sponsor
Stanford Investigators
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Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
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This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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Expanded Access Axicabtagene Ciloleucel in Tx Relapsed/Refractory T-plant-Ineligible Aggressive NHL
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A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma.
Subjects who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
Stanford is currently not accepting patients for this trial.
For more information, please contact Julianna Craig, .
Stanford Investigators
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Phase I CD8+ Memory T-Cell Donor Lymphocyte Infusion for Relapse of Hematolymphoid Malignancies
Not Recruiting
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This phase 1 trial studies the side effects and the best dose of donor CD8+ memory T-cells in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-cancer effects). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Phase I/II KTE-C19 in Combo w/ Atezolizumab in Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
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The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens.
The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL).
Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).
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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Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-MHCT
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The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)
Stanford is currently not accepting patients for this trial.
For more information, please contact Sivan Yani, 650-498-7061.
Lead Sponsor
Stanford Investigators
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Phase II Optimizing Post-Alogeneic HCT Outcomes in Lymphoma Using Ibrutinib
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This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib 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 David Miklos, M.D., .
Stanford Investigators
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Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.
Not Recruiting
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The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.
Stanford is currently not accepting patients for this trial.
For more information, please contact Stephan Busque, MD, MS, 6504986189.
Stanford Investigators
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Allo Transplant From Related Haplo Donors in Older Patients with Indolent Hematologic Malignancies
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The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+ selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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Phase III Calcineurin Inhibitor-Free Interventions for Prevention of GVHD
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The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lori Muffly, .
Stanford Investigators
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Phase II Non-Myeloablative Allogeneic Transplantation for Relapsed Follicular NHL Beyond 1st CR
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Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507251072.
Stanford Investigators
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