Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant

Summary

RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant.

Conditions

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

DRUG

busulfan

Busulfan 3.2 mg/kg/day from day -7 to day -4 as standard of care for myeloablative (bone marrow depletion) conditioning at the investigator's discretion

DRUG

cyclophosphamide

Cyclophosphamide as standard of care for myeloablative conditioning at the investigator's discretion

DRUG

cyclosporin-A

Cyclosporin-A as standard of care for GVHD prophylaxis at the investigator's discretion

DRUG

etoposide

Etoposide as standard of care for myeloablative conditioning at the investigator's discretion

DRUG

methotrexate

Methotrexate 1.5 mg/kg/day on days -3, -2, and -1 as standard of care for GVHD prophylaxis at the investigator's discretion

DRUG

rasburicase

Rasburicase 0.20 mg/kg intravenous infusion over 30 minutes for 5 to 7 days

DRUG

sirolimus

Sirolimus as standard of care for GVHD prophylaxis at the investigator's discretion

DRUG

tacrolimus

Tacrolimus as standard of care for GVHD prophylaxis at the investigator's discretion

PROCEDURE

allogeneic hematopoietic stem cell transplantation

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

total-body irradiation

Total body irradiation 13.2 Gy over 8 fractions from day -7 to day - 4 for myeloablative conditioning at the investigator's discretion

DRUG

fludarabine

Fludarabine 40 mg/m\^2/day from day -6 to day -3 as myeloablative conditioning at the investigator's discretion

DRUG

allopurinol

Allopurinol per institutional guidelines

Sponsors & Collaborators

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Bimalangshu R. Dey, MD, PhD · Massachusetts General Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2013-02-12

Completion

2013-02-12

Countries

• United States

Study Locations