drugset
drugset / Trial / 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

NCT00962767 ↗

Phase 3 Completed 168 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2002-05
Primary completion
2007-12
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody 6 mg/m2 Intravenous
Comparator MERCAPTOPURINE ANHYDROUS Small molecule 50 mg/m2 Oral
Comparator MTX Unknown 15 mg/m2 Intramuscular
Comparator Tretinoin Small molecule 45 mg/m2 Oral

Indications

acute myeloid leukemia