Last reviewed · How we verify
Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)
The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL. The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.
Details
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2009-11 |
| Completion | 2015-12 |
Conditions
- Leukemia
- Acute Lymphocytic Leukemia
Interventions
- Everolimus (RAD001)
- Cyclophosphamide
- Vincristine
- Doxorubicin
- Dexamethasone
- Mesna
- Methotrexate
- Ara-C (Cytarabine)
- Methylprednisone
- G-CSF
Primary outcomes
- Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT) — Following first two dose cycles (21 days/each), up to 42 days
The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study. A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs. - Overall Response Rate (OR) Where OR = CR + CRp + CRi — 8 courses of treatment, up to 24 weeks
Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x10\^9/L, platelet count \> 100 x10\^9/L, and blasts \< 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count \> 20 x 10\^9/L and \< 100 x 10\^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl.
Countries
United States