Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation

Summary

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.

Conditions

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

Interventions

DRUG

Cyclophosphamide

Given intravenously (IV)

DRUG

Fludarabine

Given IV

BIOLOGICAL

G-CSF

Given IV or subcutaneously (SQ)

BIOLOGICAL

Interleukin-2

Given SQ

DRUG

Melphalan

Given IV

DRUG

Thiotepa

Given IV

DRUG

Rituximab

Given IV

BIOLOGICAL

Natural killer cell therapy

Given IV

BIOLOGICAL

T-cell depleted HPC transplant

T-cell depleted hematopoietic stem cells will be infused on day 0.

BIOLOGICAL

CD45RA-depleted HPC transplant

CD45RA depleted stem cells will be infused on day 1.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Brandon Triplett, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-04-30

Completion

2016-03-31

Countries

• United States

Study Locations