Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT02259348
Phase
PHASE2
Status
Terminated

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • Chronic Myelogenous Leukemia (CML)
  • Juvenile Myelomonocytic Leukemia (JMML)
  • Myelodysplastic Syndrome (MDS)
  • Myeloid Sarcoma
  • Non-Hodgkin Lymphoma (NHL)

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given intravenously (IV)
  • Fludarabine — DRUG
    Given IV
  • G-CSF — BIOLOGICAL
    Given IV or subcutaneously (SQ)
  • Interleukin-2 — BIOLOGICAL
    Given SQ
  • Melphalan — DRUG
    Given IV
  • Thiotepa — DRUG
    Given IV
  • Rituximab — DRUG
    Given IV
  • Natural killer cell therapy — BIOLOGICAL
    Given IV
  • T-cell depleted HPC transplant — BIOLOGICAL
    T-cell depleted hematopoietic stem cells will be infused on day 0.
  • CD45RA-depleted HPC transplant — BIOLOGICAL
    CD45RA depleted stem cells will be infused on day 1.

Study Details

This pilot phase II trial studies how well a new reduced intensity conditioning regimen that includes haploidentical donor NK cells followed by the infusion of selectively T-cell depleted progenitor cell grafts work in treating younger patients with hematologic malignancies that have returned after or did not respond to treatment with a prior transplant. Giving chemotherapy and natural killer cells before a donor progenitor cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (progenitor cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy progenitor cells from a related donor are infused into the patient they make red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing specific T cells from the donor cells before the transplant may prevent this.

Key Dates

Start date
Oct 31, 2014
Status verified
Sep 2016
Primary completion
Apr 30, 2015
Completion
Mar 31, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.

Primary Outcome Measure

Percentage of Participants Engrafted by Day 42 Post-transplant [ Time Frame: Day 42 post transplantation ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

Find similar trials in Memphis, TN

By research site
St. Jude Children's Research Hospital· Memphis, TN

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