Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

Summary

This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant. Drugs used in chemotherapy, such as busulfan, fludarabine phosphate and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy such as busulfan and fludarabine phosphate before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• High Risk Acute Myeloid Leukemia
• High Risk Myelodysplastic Syndrome
• Lymphoproliferative Disorder
• Myelodysplastic Syndrome
• Myelodysplastic/Myeloproliferative Neoplasm
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Acute Myeloid Leukemia
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Recurrent High Risk Myelodysplastic Syndrome
• Recurrent Hodgkin Lymphoma
• Recurrent Myelodysplastic Syndrome
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Plasma Cell Myeloma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplantation

DRUG

Busulfan

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given PO

OTHER

Pharmacological Study

Correlative studies

DRUG

Tacrolimus

Given IV or PO

DRUG

Thiotepa

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Uday R Popat, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-05

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Drug

Yes

Countries

• United States

Study Locations