Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer

Summary

This phase I/II trial studies the side effects and best dose of donor natural killer (NK) cell therapy and to see how well it works when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, donor bone marrow transplant, mycophenolate mofetil, and tacrolimus in treating patients with hematologic cancer. Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow 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. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and tacrolimus after the transplant may stop this from happening.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Aggressive Non-Hodgkin Lymphoma
• Diffuse Large B-Cell Lymphoma
• Previously Treated Myelodysplastic Syndrome
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Recurrent Indolent Adult Non-Hodgkin Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Plasma Cell Myeloma
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Hodgkin Lymphoma
• Refractory Plasma Cell Myeloma
• Refractory Small Lymphocytic Lymphoma
• Waldenstrom Macroglobulinemia

Interventions

PROCEDURE

Allogeneic Bone Marrow Transplantation

Undergo donor bone marrow transplantation

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given PO

BIOLOGICAL

Natural Killer Cell Therapy

Given IV

DRUG

Tacrolimus

Given IV or PO

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• The Wayne D. Kuni and Joan E. Kuni Foundation

  collaborator OTHER

• 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

2008-10-13

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• United States

Study Locations