Clinical trial · Interventional
Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)
CHP-753, Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)
NCT00795886CI-TRIAL-00011517completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAPAMYCIN | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All participants
- interventionNames
- Drug: RAPAMYCIN
Primary outcomes (2)
- measure
- Number of Participants With Transplant-related Mortality
- timeFrame
- 24 months after transplant
- description
- Death not associated with relapse. We determined that if transplant related mortality(TRM) 25% at day 100 or if Grade III-IV (severe, life threatening, or disabling) acute GVHD was \>30% a stopping rule would be triggered.
- measure
- Two Year Overall Survival
- timeFrame
- 24 months after transplant
- description
- The probability that a given patient will be alive two years after transplantation. The Kaplan-Meier product limit method was used to compute the probability of overall survival to 2 years. Greenwood's formula was used to compute the standard error.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Signed informed consent. Exclusion Criteria: 1\. Organ criteria: 1. Cardiac: ECHO shortening fraction \<27% 2. Renal: Creatinine clearance \<60 ml/min/1.73 m2 3. Hepatic: Bilirubin \>1.5 mg/dl, transaminases \<3x normal 4. Infection: active viral, fungal or bacterial infection including HIV.
References
Publications (0)
Data not yet available
No reference posted for this study.