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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00962767

Collaborator

(none)

168

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myelocytic, Acute	Drug: gemtuzumab ozogamicin Drug: ATRA plus 6-MP and MTX	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: a 2 doses of gemtuzumab ozogamicn administered at monthly intervals	Drug: gemtuzumab ozogamicin 2 IV infusions 6 mg/m2 administered monthly Other Names: Arm A
Active Comparator: b 2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)	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 Other Names: Arm B

Arm

Intervention/Treatment

Experimental: a

2 doses of gemtuzumab ozogamicn administered at monthly intervals

Drug: gemtuzumab ozogamicin

2 IV infusions 6 mg/m2 administered monthly

Other Names:

Arm A

Active Comparator: b

2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)

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

Other Names:

Arm B

Outcome Measures

Primary Outcome Measures

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

Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 61 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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 risk disease.
Male and female patients age > 18 years and < 61 years.

Exclusion criteria:

Low risk patients (WBC < 10 x 109/L and platelets > 40 x 109/L).
Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
Pretreated APL.