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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Noah Merin
Study ID
NCT03524235
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 18, 2018
Status verified
Nov 2024
Primary completion
Nov 7, 2021
Completion
Nov 6, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects
    Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
  • 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.

Primary Outcome Measure

Rate of Survival at 30 days post -transplantation [ Time Frame: 30 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Cedars Sinai Medical Center· Los Angeles, CA

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