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A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
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The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.
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 Ib Tisagenlecleucel in Combo w/ Ibrutinib in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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A multi-center, open-label, phase Ib study to evaluate the safety and tolerability of the administration of tisagenlecleucel in combination with ibrutinib in patients with r/r DLBCL who have received two or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy, and who have progressed after or are not candidates for ASCT.
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/II ALLO-501A Anti-CD19 Allogenic Car-T Cell Tx &ALLO-647 Anti-CD52 Mab in R/R LBCL
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This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Stanford is currently not accepting patients for this trial.
For more information, please contact Linnea Bjornlund Nichols, 650-724-9050.
Stanford Investigators
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Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
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To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Stanford is currently not accepting patients for this trial.
For more information, please contact Kate Tierney, 6507257063.
Lead Sponsor
Stanford Investigators
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LTFU in Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
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The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.
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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Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
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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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Phase I ALLO-501 & ALLO-647 in Relapsed/Refractory Large B-Cell or Follicular Lymphoma
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The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Stanford is currently not accepting patients for this trial.
For more information, please contact Juliana Craig, 650-736-0912.
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 I Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease
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PRIMARY OBJECTIVES:
Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD.
SECONDARY OBJECTIVES:
Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joanne Otani, 650-721-2372.
Lead Sponsor
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 I/II bbT369 Dual Targeting CAR TCell DrugProduct w/ Gene Edit in Relapsed/Refractory BCell NHL
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A Phase 1/2 Study of bbT369, a dual targeting CAR T cell drug product with a gene edit, in Relapsed and/or Refractory B cell Non-Hodgkin's Lymphoma.
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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PhaseI CD19/CD22 ChimericAntigenReceptor TCells+/-NKTR-255 in Recurrent/Refractory BCellMalignancies
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This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy and NKTR-255, and to see how well they work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, 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. NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. Giving CD19/CD22-CAR T cells and chemotherapy in combination with NKTR-255 may work better in treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Matthew Abramian, 650-736-3351.
Stanford Investigators
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Phase 1 Infused Donor T Regulatory Cells in Steroid Dependent/Refractory Chronic GVHD
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Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant). This study will determine if subjects with steroid dependent/refractory cGVHD can tolerate infusion of donor regulatory T cells and whether their cGVHD responds to the infusion.
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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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 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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Phase II Imatinib and Rituximab for Cutaneous Sclerosis after Allogeneic HCT
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This randomized phase II trial is evaluating how well imatinib mesylate works compared to rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease (GVHD). Both imatinib and rituximab have been reported to decrease skin thickening and improve skin and joint flexibility in people with cutaneous sclerosis due to chronic GVHD.
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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Protocol for Research DB for HCT, Other Cellular Therapies and Marrow Toxic Injuries
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The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.
A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.
Objectives:
To learn more about what makes stem cell transplants and cellular therapies work well such as:
* Determine how well recipients recover from their transplants or cellular therapy;
* Determine how recovery after a transplant or cellular therapy can be improved;
* Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
* Determine how access to transplant or cellular therapy for different groups of patients can be improved;
* Determine how well donors recover from the collection procedures.
Stanford Investigators
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Phase II KTE-X19 in Relapsed/Refractory Mantle Cell Lymphoma
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The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (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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Pilot Study of Imatinib in Steroid Refractory Chronic Graft Versus Host Disease
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To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joanne Otani, 6507212372.
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 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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Phase I Study of FT819 in B-cell Malignancies
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This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
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 Lisocabtagene Maraleucel (JCAR017) in 2nd-Line Therapy in Adult Aggressive B-cell NHL
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This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Iglesias, 650-736-0912.
Stanford Investigators
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Phase I/II Axicabtagene Ciloleucel in Combo w/ Utomilumab in Relapsed/Refractory LargeB-CellLymphoma
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The primary objectives of this study are:
Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2
Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab as measured by complete response rate in participants with refractory large B-cell lymphoma
Stanford is currently not accepting patients for this trial.
For more information, please contact Claire Sharan, 650-721-4091.
Stanford Investigators
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Phase I B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
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This is an open label, non-randomized, single site Phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3CART into the central nervous system of adult subjects with recurrent IDH wild-type GBM using a standard 3+3 dose escalation design.
Stanford Investigators
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Phase I/IIa PBCAR20A in Relapsed/Refractory (R/R) NHL or R/R CLL or Small Lymphocytic Lymphoma
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This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.
Stanford is currently not accepting patients for this trial.
For more information, please contact David Miklos, MD, 650-498-6000.
Stanford Investigators
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Phase I/II KTE-C19 in Refractory Aggressive Non-Hodgkin Lymphoma
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This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).
The primary objectives of this study are:
* Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
* Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
* Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities
Subjects 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.
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 Anti-CD20 &Anti-CD19 Specific Chimeric Antigen Receptor in Relapsed and/or Refractory DLBCL
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DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
Stanford Investigators
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Pilot 18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
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This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Iglesias, .
Lead Sponsor
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 I ADI-001 Anti-CD20 CAR-Engineered Allogeneic Gamma Delta T Cells in B Cell Malignancies
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This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of this study is to evaluate the safety and efficacy of ADI-001 in patients with B cell malignancies.
Stanford is currently not accepting patients for this trial.
For more information, please contact David Miklos, MD, 650-723-0822.
Stanford Investigators
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CTL019 Out of Specification MAP for ALL or DLBCL Patients
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Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
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 KITE-363 / KITE-753 Autologous Anti-CD19/CD20 CAR T-Cell Therapies in R/R B-Cell Lymphoma
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The goal of this clinical study is to learn more about the safety and dosing of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.
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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Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
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The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (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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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 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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EAP for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release
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This is an expanded access protocol that will be conducted at sites qualified and approved to treat subjects with lisocabtagene maraleucel. Sometimes when lisocabtagene maraleucel is manufactured the drug does not pass all the testing results to be called lisocabtagene maraleucel. When this happens the drug is called nonconforming lisocabtagene maraleucel. The expanded access protocol will be used to allow subjects to receive nonconforming lisocabtagene maraleucel only if the potential benefit is better than the potential risk. This expanded access protocol is restricted to those subjects who were prescribed lisocabtagene maraleucel as part of their routine care.
Subjects will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.
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 tbd Optimizing ctDNA-Based MRD Assessment in DLBCL, MCL, & FL Undergoing CAR Therapy
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In this study, invesigators propose to analyze 150 DLBCL patients, 50 MCL patients, and 100 FL patients to determine the clinical utility of ctDNA- as well as circulating tumor cell (CTC)-based MRD assessment in CAR therapy patients. The project detailed in this protocol will utilize the clonoSEQ platform as specific quantification of residual DLBCL/FL/MCL and correlate its results with radiologic assessment of disease and clinical outcomes. Invesitgators predict there will be a strong correlation between ctDNA and PET/CT and dynamic changes in ctDNA will precede radiologic evidence of disease recurrence in patients following CAR therapy.
Stanford Investigators
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Phase Ib Axicabtagene Ciloleucel Reinfusion(Axi-Cel-2) in Relapsed/Refractory 2nd Line High-Risk NHL
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This is a phase Ib study to establish safety of Axi-Cel-2 in patients with Large B Cell Lymphoma (LBCL) who are at high risk of relapse.
Lead Sponsor
Stanford Investigators
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