Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant

Summary

This randomized phase III trial studies how well graft-vs-host disease (GVHD) prophylaxis works in treating patients with hematologic malignancies undergoing unrelated donor peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant (PBSCT) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, 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. Giving total-body irradiation (TBI) together with fludarabine phosphate (FLU), cyclosporine (CSP), mycophenolate mofetil (MMF), or sirolimus before transplant may stop this from happening.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Aggressive Non-Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia
• Diffuse Large B-Cell Lymphoma
• Hematopoietic and Lymphoid Cell Neoplasm
• Indolent Non-Hodgkin Lymphoma
• Mantle Cell Lymphoma
• Myelodysplastic Syndrome
• Myeloproliferative Neoplasm
• Prolymphocytic Leukemia
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Plasma Cell Myeloma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Refractory Hodgkin Lymphoma
• Small Lymphocytic Lymphoma
• T-Cell Chronic Lymphocytic Leukemia
• Waldenstrom Macroglobulinemia

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic PBSCT

DRUG

Cyclosporine

Given PO or IV

DRUG

Fludarabine Phosphate

Given IV

DRUG

Mycophenolate Mofetil

Given PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSCT

DRUG

Sirolimus

Given PO

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Brenda Sandmaier · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2016-10-08

Completion

2017-06-30

Countries

• United States
• Denmark
• Germany

Study Locations