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

Phase 1

Completed

• Conditions: CLL; Chronic Lymphocytic Leukemia; Lymphoma; Hodgkin Lymphoma; Multiple Myeloma
• Interventions: Radiation: Total Body Irradiation; Procedure: Haploidentical Stem Cell Transplantation; Biological: CD56-Enriched Donor Lymphocyte Infusion; Drug: Bendamustine; Drug: Fludarabine; Drug: Rituximab

• Registration Number: NCT03524235
• Lead Sponsor: Noah Merin

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Study Start: 2018-07-18
• Primary Completion: 2021-11-07
• Status Verified: 2024-11
• Study Completion: 2024-11-06
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects	Total Body Irradiation	Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
Subjects	Haploidentical Stem Cell Transplantation	Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
Subjects	CD56-Enriched Donor Lymphocyte Infusion	Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
Subjects	Bendamustine	Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
Subjects	Fludarabine	Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
Subjects	Rituximab	Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion

Primary Outcome Measures

Name	Time	Method
Rate of Survival at 30 days post -transplantation	30 Days	Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT alive at 30 days post-transplantation.

Secondary Outcome Measures

Name	Time	Method
Rate of severe chronic GVHD at 365 days post-transplantation	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
Rate of neutrophil engraftment at 30 days	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	100 days	Proportion of patients with platelets \> 20/uL with no platelet transfusions within the prior 7 days at day 100 post-transplantation.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States