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

Phase 3

Completed

• Conditions: Leukemia, Myelocytic, Acute
• Interventions: Drug: gemtuzumab ozogamicin; Drug: ATRA plus 6-MP and MTX

• Registration Number: NCT00962767
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-08
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-19
• Last Update Submitted: 2009-08-19
• Study First Posted: 2009-08-20
• Last Update Posted: 2009-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a	gemtuzumab ozogamicin	2 doses of gemtuzumab ozogamicn administered at monthly intervals
b	ATRA plus 6-MP and MTX	2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)

Primary Outcome Measures

Name	Time	Method
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.	5 years

Secondary Outcome Measures

Name	Time	Method
Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.	5 years