Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation

Summary

This phase II trial studies how well 3 different drug combinations prevent graft versus host disease (GVHD) after donor stem cell transplant. Calcineurin inhibitors, such as cyclosporine and tacrolimus, may stop the activity of donor cells that can cause GVHD. Chemotherapy drugs, such as cyclophosphamide and methotrexate, may also stop the donor cells that can lead to GVHD while not affecting the cancer-fighting donor cells. Immunosuppressive therapy, such as anti-thymocyte globulin (ATG), is used to decrease the body's immune response and reduces the risk of GVHD. It is not yet known which combination of drugs: 1) ATG, methotrexate, and calcineurin inhibitor 2) cyclophosphamide and calcineurin inhibitor, or 3) methotrexate and calcineurin inhibitor may work best to prevent graft versus host disease and result in best overall outcome after donor stem cell transplant.

Conditions

• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Chronic Myelomonocytic Leukemia
• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematopoietic and Lymphoid System Neoplasm
• Myelodysplastic Syndrome
• Myelofibrosis
• Myeloproliferative Neoplasm
• Recurrent Acute Myeloid Leukemia
• Recurrent Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Refractory Acute Myeloid Leukemia
• Therapy-Related Acute Myeloid Leukemia

Interventions

BIOLOGICAL

Anti-Thymocyte Globulin

Given IV

DRUG

Busulfan

Given IV or PO

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given IV or PO

DRUG

Fludarabine Phosphate

Given IV

DRUG

Methotrexate

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo peripheral blood stem cell transplantation

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Tacrolimus

Given IV or PO

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Masumi Ueda Oshima · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2023-09-17

Completion

2023-09-17

FDA Drug

Yes

Countries

• United States

Study Locations