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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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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
Stanford Investigators
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Phase I Fructo-Oligosaccharides in Allogeneic Hematopoietic Stem Cell Transplantation (HCT)
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This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Nutritional supplements such as fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with blood cancer undergoing donor stem cell transplant.
Stanford is currently not accepting patients for this trial.
For more information, please contact Courtney Greene, 650-723-0387.
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 Ib/2 Ibrutinib in Steroid Dependent or Refractory Chronic GVHD
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The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Janet McDowell, 650-725-1647.
Stanford Investigators
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Phase II Donor Statin Tx for Prevention of Severe Acute GVHD after Myeloablative HCT
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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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Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
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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 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
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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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Phase II Ruxolitinib in Combo w/ Corticosteroids in Steroid-Refractory Acute Graft-vs-Host Disease
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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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Phase III Transplantation of NiCord vs Unmanipulated UmbilicalCordBlood in HematologicalMalignancies
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This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrew Rezvani,, MD, 650-498-6000.
Stanford Investigators
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Longitudinal Study of Immune Mediated Disorders After Allogeneic HCT Protocol
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The purpose of this research study is to better understand the onset and course of graft versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.
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 III Standard-Dose Combo Chemo or High-Dose Combo Chemo +Stem Cell T-plant in Germ Cell Tumors
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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
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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 Umbilical Cord Blood vs Bone Marrow in Hematologic Malignancies
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Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.
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 III Axicabtagene Ciloleucel vs SoC Therapy in Relapsed/Refractory Diffuse Large BCell Lymphoma
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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
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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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Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes
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This randomized phase II trial studies how well donor umbilical cord blood transplant with or without ex-vivo expanded cord blood progenitor cells works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy stem cells and ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded cord blood progenitor cells is more effective than giving a donor umbilical cord blood transplant alone.
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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Phase III Tacrolimus/Methotrexate vs Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in PBSCT
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1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation.
1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.
Stanford is currently not accepting patients for this trial.
For more information, please contact Sivan Yani, 650-497-0330.
Stanford Investigators
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Phase II Ibrutinib Maintenance After Reduced-Intensity Conditioning &Allogeneic HCT in AcuteLeukemia
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This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth of tumor 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 Courtney Greene, 650-723-0387.
Stanford Investigators
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Phase II Cryopreserved Cord Blood Units (CBUs) in Unrelated HSCT in Pediatric & Adult Patients
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This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
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/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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Phase III Expanded Access Omidubicel in Allogeneic Transplantation in Hematological Malignancies
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Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Stanford is currently not accepting patients for this trial.
For more information, please contact Andrew Rezvani,, MD, 650-498-6000.
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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Phase tbd Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress
Recruiting
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The purpose of this research is to evaluate aromatherapy inhaler use and how it may impact cancer distress and coping by patients in the first few days after hematopoietic stem cell transplant (HSCT).
Lead Sponsor
Stanford Investigators
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