Haploidentical Stem Cell Transplant With Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL
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|ClinicalTrials.gov Identifier: NCT03524235|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2018
Last Update Posted : December 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma CLL Chronic Lymphocytic Leukemia Lymphoma Hodgkin Lymphoma||Radiation: Total Body Irradiation Procedure: Haploidentical Stem Cell Transplantation Biological: CD56-Enriched Donor Lymphocyte Infusion Drug: Bendamustine Drug: Fludarabine Drug: Rituximab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||IIT2017-03-Merin-HaploBFR: Bendamustine, Fludarabine, And Rituximab Conditioning For Haploidentical Stem Cell Transplantation With CD56-Enriched Donor Cell Infusion For Relapsed/Refractory Lymphoma, Multiple Myeloma, and CLL|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2024|
Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
Radiation: Total Body Irradiation
Pre-Transplantation Total Body Irradiation
Other Name: TBI
Procedure: Haploidentical Stem Cell Transplantation
Haploidentical Stem Cell Transplantation
Biological: CD56-Enriched Donor Lymphocyte Infusion
CD56-Enriched Donor Lymphocyte Infusion
Other Name: Bendeka; Treanda
Other Name: Fludara
Pre-Transplantation Rituximab (Rituximab for lymphoma diagnosis only)
Other Name: Rituxan
No Intervention: Controls
Patients undergoing standard-of-care reduced-intensity peripheral blood allogeneic stem cell transplantation (any indication, donor source, conditioning regimen) using PTCy GVHD prophylaxis.
- Rate of Survival at 30 days post -transplantation [ Time Frame: 30 Days ]Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT alive at 30 days post-transplantation.
- Rate of neutrophil engraftment at 30 days [ Time Frame: 30 days ]
Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT with neutrophil engraftment at 30 days post-transplantation.
-Neutrophil engraftment is defined as ANC recovery to >500/uL.
- Rate of platelet recovery at 100 days post-transplantation [ Time Frame: 100 days ]Proportion of patients with platelets > 20/uL with no platelet transfusions within the prior 7 days at day 100 post-transplantation.
- Rate of severe chronic GVHD at 365 days post-transplantation [ Time Frame: 365 days ]
Proportion of patients with severe chronic GVHD at day 365 post-transplantation.
-Severe chronic GVHD is defined by NIH Consensus Criteria for GVHD severity
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): NCT03524235
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Noah Merin, MD, PhD||Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute|