Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant
Rasburicase to Prevent Graft -Versus-Host Disease
3 other identifiers
interventional
46
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2013
CompletedResults Posted
Study results publicly available
April 11, 2017
CompletedMay 25, 2017
April 1, 2017
5.1 years
August 6, 2007
February 27, 2017
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)
aGVHD severity was determined using International Bone Marrow Transplant Registry (IBMTR) scale stage and grade of the skin, liver and gut. Stage 1: Skin=maculopapular rash \<25% of body surface; Liver=Bilirubin 2-3 mg/dL and Gut=500-999 mL diarrhea/day or peristent nausea with histologic evidence of GvHD. Stage 2: Skin=maculopapular rash 25-50% of body surface; Liver=Bilirubin 3.1-6 mg/dL and Gut=1000-1499 mL diarrhea/day. Stage 3: Skin=maculopapular rash \>50% of body surface; Liver=Bilirubin 6.1-15 mg/dL and Gut=≥1500 mL diarrhea/day. Stage 4: Skin=generalized erythroderma with bulla formation; Liver=Bilirubin \>15 mg/dL and Gut=severe abdominal pain. Grade 1: Stage 1-2 rash; no liver or gut involvement. Grade II: Stage 3 rash, or stage 1 liver involvement, or stage 1 gut involvement. Grade III: None to stage 3 skin rash with stage 2-3 liver, or stage 2-4 gut involvement. Grade IV: Stage 4 skin rash, or stage 4 liver involvement.
Up to 71 months
Secondary Outcomes (3)
Uric Acid Levels
Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6
Number of Participant With Adverse Events (AE)
Up to 71 months
Graft-versus-host and Host-versus-graft Immune Responses
Days -2, 0, and Days 14, 21 and 35 days post-transplant
Study Arms (2)
Rasburicase Group
EXPERIMENTALMyeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
Control Group
OTHERHistorical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
Interventions
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
Cyclophosphamide as standard of care for myeloablative conditioning at the investigator's discretion
Cyclosporin-A as standard of care for GVHD prophylaxis at the investigator's discretion
Etoposide as standard of care for myeloablative conditioning at the investigator's discretion
Methotrexate 1.5 mg/kg/day on days -3, -2, and -1 as standard of care for GVHD prophylaxis at the investigator's discretion
Rasburicase 0.20 mg/kg intravenous infusion over 30 minutes for 5 to 7 days
Sirolimus as standard of care for GVHD prophylaxis at the investigator's discretion
Tacrolimus as standard of care for GVHD prophylaxis at the investigator's discretion
Total body irradiation 13.2 Gy over 8 fractions from day -7 to day - 4 for myeloablative conditioning at the investigator's discretion
Fludarabine 40 mg/m\^2/day from day -6 to day -3 as myeloablative conditioning at the investigator's discretion
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114-2617, United States
Related Publications (1)
Yeh AC, Brunner AM, Spitzer TR, Chen YB, Coughlin E, McAfee S, Ballen K, Attar E, Caron M, Preffer FI, Yeap BY, Dey BR. Phase I study of urate oxidase in the reduction of acute graft-versus-host disease after myeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2014 May;20(5):730-4. doi: 10.1016/j.bbmt.2014.02.003. Epub 2014 Feb 12.
PMID: 24530972RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bimalangshu R. Dey, MD, PhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Bimalangshu R. Dey, MD, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
August 6, 2007
First Posted
August 8, 2007
Study Start
January 1, 2008
Primary Completion
February 12, 2013
Study Completion
February 12, 2013
Last Updated
May 25, 2017
Results First Posted
April 11, 2017
Record last verified: 2017-04