Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Summary

This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving MMF and tacrolimus with or without sirolimus after transplant may stop this from happening.

Conditions

• Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
• Previously Treated Myelodysplastic Syndrome
• Refractory Chronic Lymphocytic Leukemia
• Refractory Plasma Cell Myeloma
• Waldenstrom Macroglobulinemia
• Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Adult Acute Lymphoblastic Leukemia in Remission
• Adult Acute Myeloid Leukemia in Remission
• Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
• Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
• Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
• Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Childhood Acute Lymphoblastic Leukemia in Remission
• Childhood Acute Myeloid Leukemia in Remission
• Childhood Burkitt Lymphoma
• Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Childhood Diffuse Large Cell Lymphoma
• Childhood Immunoblastic Lymphoma
• Childhood Myelodysplastic Syndrome
• Stage II Contiguous Adult Burkitt Lymphoma
• Stage II Contiguous Adult Diffuse Large Cell Lymphoma
• Stage II Contiguous Adult Diffuse Mixed Cell Lymphoma
• Stage II Contiguous Adult Diffuse Small Cleaved Cell Lymphoma
• Stage II Adult Contiguous Immunoblastic Lymphoma
• Stage II Contiguous Adult Lymphoblastic Lymphoma
• Stage II Grade 1 Contiguous Follicular Lymphoma
• Stage II Grade 2 Contiguous Follicular Lymphoma
• Stage II Grade 3 Contiguous Follicular Lymphoma
• Stage II Contiguous Mantle Cell Lymphoma
• Stage II Non-Contiguous Adult Burkitt Lymphoma
• Stage II Non-Contiguous Adult Diffuse Large Cell Lymphoma
• Stage II Non-Contiguous Adult Diffuse Mixed Cell Lymphoma
• Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma
• Stage II Adult Non-Contiguous Immunoblastic Lymphoma
• Stage II Non-Contiguous Adult Lymphoblastic Lymphoma
• Stage II Grade 1 Non-Contiguous Follicular Lymphoma
• Stage II Grade 2 Non-Contiguous Follicular Lymphoma
• Stage II Grade 3 Non-Contiguous Follicular Lymphoma
• Stage II Non-Contiguous Mantle Cell Lymphoma
• Stage II Small Lymphocytic Lymphoma
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Burkitt Lymphoma
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Adult Diffuse Mixed Cell Lymphoma
• Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Recurrent Adult Immunoblastic Lymphoma
• Recurrent Adult Lymphoblastic Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Recurrent Childhood Anaplastic Large Cell Lymphoma
• Recurrent Childhood Large Cell Lymphoma
• Recurrent Childhood Lymphoblastic Lymphoma
• Recurrent Childhood Burkitt Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Small Lymphocytic Lymphoma
• Recurrent Childhood Hodgkin Lymphoma
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Secondary Myelodysplastic Syndrome
• Stage I Adult Burkitt Lymphoma
• Stage I Adult Diffuse Large Cell Lymphoma
• Stage I Adult Diffuse Mixed Cell Lymphoma
• Stage I Adult Immunoblastic Lymphoma
• Stage I Adult Lymphoblastic Lymphoma
• Stage I Childhood Anaplastic Large Cell Lymphoma
• Stage I Childhood Large Cell Lymphoma
• Stage I Childhood Lymphoblastic Lymphoma
• Stage I Childhood Burkitt Lymphoma
• Stage I Grade 1 Follicular Lymphoma
• Stage I Grade 2 Follicular Lymphoma
• Stage I Grade 3 Follicular Lymphoma
• Stage I Mantle Cell Lymphoma
• Stage I Marginal Zone Lymphoma
• Stage I Small Lymphocytic Lymphoma
• Stage II Childhood Anaplastic Large Cell Lymphoma
• Stage II Childhood Lymphoblastic Lymphoma
• Stage II Childhood Burkitt Lymphoma
• Stage III Adult Burkitt Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage III Adult Diffuse Mixed Cell Lymphoma
• Stage III Adult Diffuse Small Cleaved Cell Lymphoma
• Stage III Adult Immunoblastic Lymphoma
• Stage III Adult Lymphoblastic Lymphoma
• Stage III Childhood Anaplastic Large Cell Lymphoma
• Stage III Childhood Large Cell Lymphoma
• Stage III Childhood Lymphoblastic Lymphoma
• Stage III Childhood Burkitt Lymphoma
• Stage III Grade 1 Follicular Lymphoma
• Stage III Grade 2 Follicular Lymphoma
• Stage III Grade 3 Follicular Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage III Marginal Zone Lymphoma
• Stage III Small Lymphocytic Lymphoma
• Stage IV Adult Burkitt Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Diffuse Mixed Cell Lymphoma
• Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
• Stage IV Adult Immunoblastic Lymphoma
• Stage IV Adult Lymphoblastic Lymphoma
• Stage IV Childhood Anaplastic Large Cell Lymphoma
• Stage IV Childhood Large Cell Lymphoma
• Stage IV Childhood Lymphoblastic Lymphoma
• Stage IV Childhood Burkitt Lymphoma
• Stage IV Grade 1 Follicular Lymphoma
• Stage IV Grade 2 Follicular Lymphoma
• Stage IV Grade 3 Follicular Lymphoma
• Stage IV Mantle Cell Lymphoma
• Stage IV Marginal Zone Lymphoma
• Stage IV Small Lymphocytic Lymphoma

Interventions

DRUG

Fludarabine Phosphate

Given IV

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplantation

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplantation

DRUG

Tacrolimus

Given IV or PO

DRUG

Mycophenolate Mofetil

Given PO

DRUG

Sirolimus

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Brenda Sandmaier · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2011-05-31

Completion

2015-05-08

Countries

• United States
• Denmark
• Germany

Study Locations