CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
busulfan +12 moredrug
Likely dose
busulfan 3.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00513474
NCT00513474Phase 1Completed

Rasburicase to Prevent Graft -Versus-Host Disease

Massachusetts General Hospital·interventional·Posted Aug 8, 2007·Updated May 25, 2017

In Brief

A Phase 1 clinical trial evaluating busulfan, cyclophosphamide, and 11 other interventions for Chronic Myeloproliferative Disorders and 6 related conditions. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2007
Enrollment StartJan 1, 2008
Primary CompletionFeb 12, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 18.9 years ago

Interventions

busulfandrug

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

cyclophosphamidedrug

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

cyclosporin-Adrug

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

etoposidedrug

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

methotrexatedrug

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

rasburicasedrug

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

sirolimusdrug

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

tacrolimusdrug

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

allogeneic hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure

total-body irradiationradiation

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

fludarabinedrug

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

allopurinoldrug

Allopurinol per institutional guidelines