Clinical trial · Interventional
Rapamycin in Relapsed Acute Lymphoblastic Leukemia
NCT00874562CI-TRIAL-00024881completedPhase 1ClinicalTrials.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)
This is a research study designed to look at the biological effects of two drugs on leukemia cells. In this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's immune system from working normally. It has been used for many years after kidney transplants to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat leukemia and other cancers.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Corticosteroid | Drug | — | UNRESOLVED |
| Rapamycin | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Steroid Only
- description
- Corticosteroid Alone
- interventionNames
- Drug: Corticosteroid
- type
- ACTIVE_COMPARATOR
- label
- Steroid plus Rapamycin
- description
- Corticosteroid plus Rapamycin
- interventionNames
- Drug: Corticosteroid
- Drug: Rapamycin
Primary outcomes (2)
- measure
- Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 365 Days
Show eligibility criteria text
Inclusion Criteria: * Documented acute lymphoblastic leukemia (L1 or L2 subtypes) * First or subsequent relapse * 365 days of age or older * Greater than 7 days from any chemotherapy or immunotherapy, with the exception of intrathecal chemotherapy * Absolute peripheral leukemia blast count of 1000 cells/ul or greater * Patient (or parent/guardian if patient is less than 18 years of age) must sign informed consent Exclusion Criteria: * Burkitts leukemia (acute lymphoblastic leukemia L3 subtype) * Uncontrolled active infection * Pregnancy or mothers who are nursing * Patient currently taking rapamycin * Patients with significant liver dysfunction as outlined in protocol * Severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into the study * Active psychiatric disease, substance abuse, or mental illness that would interfere with cooperation with the requirements of the trial
References
Publications (0)
Data not yet available
No reference posted for this study.