Nivolumab/Ipilimumab-Primed Immunotransplant for DLBCL
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|ClinicalTrials.gov Identifier: NCT03305445|
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma||Drug: Ipilimumab Drug: Nivolumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This multi-center study open-label trial will enroll a single cohort of relapsed/refractory diffuse large B cell lymphoma (DLBCL) patients whom are ineligible for autologous stem cell transplant (ASCT).|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center Phase Ib/II Trial of Nivolumab/Ipilimumab-Primed Immunotransplant for Relapsed/Refractory Diffuse Large B Cell Lymphoma Patients.|
|Actual Study Start Date :||May 14, 2018|
|Estimated Primary Completion Date :||November 27, 2021|
|Estimated Study Completion Date :||November 27, 2021|
Experimental: Pts with Diffuse Large B Cell Lymphoma
Patients with DLBCL not eligible for autologous stem cell transplant. All patients will receive dual checkpoint blocking antibody (DCBA) therapy of ipilimumab and nivolumab given at three week intervals, two times before, and two times following "immunotransplant" in which T cells (in whole PBMCs) are cryopreserved and re-infused (adoptive T cell transfer or ATCT) following lymphodepleting chemotherapy regimen, currently being employed in adoptive T cell therapies.
Other Name: Yervoy
Other Name: Opdivo
- Dose Limiting Toxicities (DLTs) [ Time Frame: 3 months ]DLTs recorded and graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. for Phase 1B part of study
- Completion Remission (CR) Rate [ Time Frame: 3 months ]The proportion of patients who have achieved complete remission as per Lugano criteria which is complete metabolic response even with a persistent mass.
- Progression Free Survival (PFS) [ Time Frame: 2 years ]PFS will be estimated using the method of Kaplan-Meier where PFS is defined as the time from Adoptive T cell transfer (ATCT) until the first recurrence or progression of disease as per Lugano criteria (3), or date of death if the subject dies from any cause before progression is documented.
- Overall Survival (OS) [ Time Frame: 2 years ]OS from the time of ATCT (D0) until recorded date of death.
- IgVH level [ Time Frame: 2 years ]Rate and time to achieving molecular remission as determined by serum analysis for persistent IgVH by PCR
- Delayed CR [ Time Frame: 2 years ]Delayed CR defined as the proportion of patients who achieved CR reported as a percentage of the total number of subjects enrolled for both FA and PP populations.
- Overall Response Rate (ORR) [ Time Frame: 2 years ]ORR, defined as CR+PR+SD (complete remission + partial remission + stable disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305445
|Contact: Alexis Mark||212-824-7324||Alexis.Mark@mssm.edu|
|Contact: Martine Van Voorthuysen||(212) 824-7275||Martine.VanVoorthuysen@mssm.edu|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Alexis Mark 212-824-7324 Alexis.Mark@mssm.edu|
|Contact: Martine Van Voorthuysen (212) 824-7275 Martine.VanVoorthuysen@mssm.edu|
|Principal Investigator: Joshua Brody, MD|
|Principal Investigator:||Joshua Brody, MD||Icahn School of Medicine at Mount Sinai|