Haploidentical Stem Cell Transplant With Prophylactic Natural Killer DLI for Lymphoma Multiple Myeloma and CLL

  • STATUS
    Recruiting
  • End date
    May 26, 2023
  • participants needed
    30
  • sponsor
    Noah Merin
Updated on 26 January 2021
cancer
remission
graft versus host disease
total body irradiation
fludarabine
tacrolimus
cyclophosphamide
hla-a
lymphoma
multiple myeloma
hodgkin's disease
rituximab
flow cytometry
antiretroviral agents
antiviral
cell transplantation
leukemia
bone marrow procedure
transplant conditioning
venetoclax
TP53
chemotherapy regimen
autograft
diffuse large b-cell lymphoma
b-cell lymphoma
t-cell lymphoma
bendamustine
recurrent chronic lymphocytic leukemia
aggressive non-hodgkin's lymphoma
low grade lymphoma

Summary

This study seeks to examine the investigational use of the conditioning regimen (bendamustine, fludarabine, and rituximab) prior to haploidentical peripheral blood allogeneic stem cell transplantation with Post-Transplant Cyclophosphamide. The study will also test the investigational use of CD56-enriched Donor Lymphocyte Infusion to see if this treatment is safe, and whether or not it will help patients achieve better outcomes post-transplant, including reduced risk of Graft-Versus-Host Disease (GVHD), and preventing disease relapse.

Description

This is a single center Phase I trial of a new haploidentical stem cell transplant regimen intended to assess safety. Two groups of patients are planned: patients with lymphoma and patients with multiple myeloma. Each subject will receive a haploidentical stem cell transplantation using peripheral blood stem cells. Bendamustine-fludarabine-rituximab-TBI conditioning will be used, followed by stem cell infusion, with Post-Transplant Cyclophosphamide and tacrolimus for GVHD prophylaxis. Patients will receive a CD56-selected DLI on day +8. Evaluations will be taken at baseline and at each of the study visits. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be one year. Total duration of the study is expected to be three years.

Details
Condition Hodgkin's Disease, Multiple Myeloma, Lymphoma, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Lymphoproliferative disorders, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, lymphomas, multiple myeloma (mm), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment Rituximab, Fludarabine, Total body irradiation, Bendamustine, Haploidentical Stem Cell Transplantation, CD56-Enriched Donor Lymphocyte Infusion
Clinical Study IdentifierNCT03524235
SponsorNoah Merin
Last Modified on26 January 2021

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