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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Leukemia, Myelocytic, Acute

Treatments: Drug: ATRA plus 6-MP and MTX; Drug: gemtuzumab ozogamicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962767

0903X-101128

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 61 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

a

Experimental group

Description:

2 doses of gemtuzumab ozogamicn administered at monthly intervals

Treatment:

Drug: gemtuzumab ozogamicin

b

Active Comparator group

Description:

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

Treatment:

Drug: ATRA plus 6-MP and MTX