Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

Summary

This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant 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 together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.

Conditions

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

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplant

DRUG

Cyclosporine

Given PO or IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplant

DRUG

Sirolimus

Given PO

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

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

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-01

Primary Completion

2018-11-23

Completion

2019-02-11

Countries

• United States
• Denmark

Study Locations