NCT03524235

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Noah Merin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• CLL
• Chronic Lymphocytic Leukemia
• Lymphoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
RADIATION	Total Body Irradiation	Pre-Transplantation Total Body Irradiation
PROCEDURE	Haploidentical Stem Cell Transplantation	Haploidentical Stem Cell Transplantation
BIOLOGICAL	CD56-Enriched Donor Lymphocyte Infusion	CD56-Enriched Donor Lymphocyte Infusion
DRUG	Bendamustine	Pre-Transplantation Bendamustine
DRUG	Fludarabine	Pre-Transplantation Fludarabine
DRUG	Rituximab	Pre-Transplantation Rituximab (Rituximab for lymphoma diagnosis only)

Timeline

• Start date: 2018-07-18
• Primary completion: 2021-11-07
• Completion: 2024-11-06
• First posted: 2018-05-14
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study