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

NCT03524235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Miltenyi Biomedicine GmbH

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY

  • Noah Merin

    lead OTHER

Principal Investigators

  • Noah Merin, MD, PhD · Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2021-11-07
Completion
2024-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524235 on ClinicalTrials.gov