Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)

Completed · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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). Investigator initiated; four participating institutions; Phase II pilot study

Key facts

Study ID

NCT00795886

Run by

University of Utah

People needed

63

Starts

2005-08-01

Expected to finish

2010-03-01

Last updated by the study team

2013-07-31

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Primary Children's Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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