Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
1 other identifier
interventional
105
1 country
3
Brief Summary
The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2002
Shorter than P25 for phase_2
3 active sites
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
Study Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedMarch 8, 2012
March 1, 2012
9 months
September 6, 2005
March 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
- Donors (both related and unrelated) who are identical at 6 HLA loci.
- Age greater than 18
- ECOG Performance Status 0-2
- Life expectancy of greater than 100 days.
You may not qualify if:
- Pregnancy
- Evidence of HIV infection
- Heart failure uncontrolled by medications
- Total Bilirubin \> 2.0mg/dl due to hepatocellular dysfunction
- AST \> 90
- Serum creatinine \> 2.0
- Cholesterol \> 300 mg/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (3)
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edwin P. Alyea, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 7, 2005
Study Start
July 1, 2002
Primary Completion
April 1, 2003
Study Completion
April 1, 2003
Last Updated
March 8, 2012
Record last verified: 2012-03