Status:
COMPLETED
Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
Objectives: Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL). Invest...
Detailed Description
Objectives: Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL). Rapamy...
Eligibility Criteria
Inclusion
- Pediatric patients' ages (0 - 21 years) with lymphoid malignancies considered for allogeneic bone marrow transplant from HLA-identical sibling donor, single antigen mismatched related or unrelated donor marrow /peripheral blood stem cell (PBSC) or cord blood available for marrow donation.
- First remission:
- if remission not achieved by day28
- high risk cytogenetic features, including t(9;22) or t(4;11) Second or third remission
- Signed informed consent.
Exclusion
- 1\. Organ criteria:
- Cardiac: ECHO shortening fraction \<27%
- Renal: Creatinine clearance \<60 ml/min/1.73 m2
- Hepatic: Bilirubin \>1.5 mg/dl, transaminases \<3x normal
- Infection: active viral, fungal or bacterial infection including HIV.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00795886
Start Date
August 1 2005
End Date
March 1 2010
Last Update
July 31 2013
Active Locations (1)
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1
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112