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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00962767 | Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission | PHASE3 | COMPLETED | 168 | — | — | May 1, 2002 | Dec 1, 2007 | Aug 20, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| a | EXPERIMENTAL | 2 doses of gemtuzumab ozogamicn administered at monthly intervals |
| b | ACTIVE_COMPARATOR | 2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX) |
| Name | Type | Description |
|---|---|---|
| gemtuzumab ozogamicin | DRUG | 2 IV infusions 6 mg/m2 administered monthly |
| ATRA plus 6-MP and MTX | DRUG | 6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO |
Inclusion criteria: 1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high r...