Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Summary

This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.

Conditions

• Acute Biphenotypic Leukemia
• Acute Erythroid Leukemia in Remission
• Acute Leukemia in Remission
• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukaemia With Prior Myelodysplastic Syndrome
• Acute Myeloid Leukemia in Remission
• Acute Myeloid Leukemia With FLT3/ITD Mutation
• Acute Myeloid Leukemia With Inv(3)(Q21Q26.2); RPN1-EVI1
• Acute Myeloid Leukemia With Multilineage Dysplasia
• Acute Myeloid Leukemia With t(6;9)
• Acute Undifferentiated Leukemia
• Adult Acute Lymphoblastic Leukemia in Complete Remission
• B Acute Lymphoblastic Leukemia With T(1;19)(Q23;P13.3); E2A-PBX1 (TCF3-PBX1)
• Ph+ ALL
• Burkitt Lymphoma
• Childhood Acute Lymphoblastic Leukemia in Complete Remission
• DS Stage II Plasma Cell Myeloma
• DS Stage III Plasma Cell Myeloma
• Myelodysplastic Syndrome
• Recurrent Anaplastic Large Cell Lymphoma
• Blasts Under 5 Percent of Bone Marrow Nucleated Cells
• Recurrent Follicular Lymphoma
• Recurrent Hodgkin Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma
• Secondary Acute Myeloid Leukemia
• T Lymphoblastic Lymphoma
• Hematopoietic Cell Transplant Recipient

Interventions

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim

Given SQ

DRUG

Fludarabine Phosphate

Given IV

DRUG

Mycophenolate Mofetil

Given PO

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo PBSC

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSC

DRUG

Tacrolimus

Given IV or PO

RADIATION

Total-Body Irradiation

Undergo total-body irradiation (TBI)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Rachel B. Salit · 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

2010-05-19

Primary Completion

2021-10-07

Completion

2021-10-07

FDA Drug

Yes

Countries

• United States

Study Locations