Trials / Completed
CompletedNCT00962767
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
A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 61 Years
- Healthy volunteers
- Not accepted
Summary
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gemtuzumab ozogamicin | 2 IV infusions 6 mg/m2 administered monthly |
| DRUG | ATRA plus 6-MP and MTX | 6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2009-08-20
- Last updated
- 2009-08-20
Source: ClinicalTrials.gov record NCT00962767. Inclusion in this directory is not an endorsement.