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

PHASE3CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Leukemia, Myelocytic, Acute
Interventions
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

All Listed Sponsors
lead

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

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 | Biotech Hunter | Biotech Hunter