Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01523977 | Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL | PHASE1 | COMPLETED | 22 | — | — | Nov 1, 2011 | Nov 1, 2018 | Jul 18, 2024 | 8 | United States |
To determine the safety and feasibility of treatment with everolimus in combination with vincristine, prednisone, PEG-asparaginase and doxorubicin in patients with relapsed acute lymphoblastic leukemia (ALL)
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Orally, daily days 1-32 per assigned dose level |
| Prednisone | DRUG | 40 mg/m2/day orally 3 x daily days 4-32 |
| Vincristine | DRUG | 1.5 mg/m2 IV daily on days 4, 11, 18, and 25 |
| PEG-Asparaginase | DRUG | 2,500 U/m2 IV 1 x daily on days 5 and 18 |
| Doxorubicin | DRUG | 30 mg/m2 IV on days 4 and 5 |
| Dexrazoxane | DRUG | 300 mg/m2 IV on days 4 and 5 |
Inclusion Criteria: * ALL in first bone marrow relapse occuring \> 18 months from initial diagnosis * Normal organ function * Maximum prior cumulative doxorubicin dose of \</= 360 mg/m2 or equivalent Exclusion Criteria: * Prior therapy for ALL except for intrathecal (IT) chemotherapy * Pregnant o...