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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Leukemia, Myelocytic, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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a

2 doses of gemtuzumab ozogamicn administered at monthly intervals

Group Type EXPERIMENTAL

gemtuzumab ozogamicin

Intervention Type DRUG

2 IV infusions 6 mg/m2 administered monthly

b

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

Group Type ACTIVE_COMPARATOR

ATRA plus 6-MP and MTX

Intervention Type DRUG

6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO

Interventions

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gemtuzumab ozogamicin

2 IV infusions 6 mg/m2 administered monthly

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Arm A Arm B

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Male and female patients age \> 18 years and \< 61 years.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No