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Phase 2 N=63 Treatment

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

Acute Lymphoblastic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00795886 ↗
Enrolled (actual)
63
Serious AEs
12.7%
Results posted
May 2012
Primary outcome: Primary: Number of Participants With Transplant-related Mortality — 8 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
RAPAMYCIN (Drug)
Age
Pediatric, Adult
Sex
All
Sponsor
University of Utah
Primary completion
Mar 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Transplant-related Mortality		 8 —
PRIMARY
Two Year Overall Survival		 0.73 —
SECONDARY
Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD)		 38 —

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

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • Organ criteria:
  • Cardiac: ECHO shortening fraction 1.5 mg/dl, transaminases <3x normal
  • Infection: active viral, fungal or bacterial infection including HIV.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00795886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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