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

Completed · Phase 1

Conditions studied: Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

In brief

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.

Key facts

Study ID

NCT00513474

Run by

Massachusetts General Hospital

People needed

46

Starts

2008-01-01

Expected to finish

2013-02-12

Last updated by the study team

2017-05-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a "currently active" second malignancy other than non-melanoma skin cancers can only be registered if survival from the second malignancy is expected to be more than 1 year
• Ejection fraction ≥ 45% by either radioisotope Multiple Gated Acquisition Scan (MUGA) scan or Echocardiogram (ECHO)
• Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ≥ 50% of predicted with no symptomatic pulmonary disease
• Mini Mental Status Exam Score ≥ 20
• Patients must have an expected life expectancy of at least 3 months
• Patients with symptomatic visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled
• Patients with a fungal infection must have had treatment for at least one month and must have proof of regression of the infection prior to enrollment
• Patients may be on antibiotics at the time of transplant

You may not qualify if…

• Human Immunodeficiency Virus (HIV) infection
• Uncontrolled diabetes mellitus
• Active congestive heart failure from any cause
• Previous history of congestive heart failure allowed
• Active angina pectoris
• Oxygen-dependent obstructive pulmonary disease
• Failure to demonstrate adequate compliance with medical therapy and follow-up
• Known history of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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