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Completed

NCT Number: 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

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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Key information

Conditions

Leukemia, Myelocytic, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemtuzumab Ozogamicin

Drug

2 IV infusions 6 mg/m2 administered monthly

Other names: Arm A

ATRA plus 6-MP and MTX

Drug

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

Other names: Arm B

Primary outcomes

  1. 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.

    Time frame: 5 years

Secondary outcomes

  1. Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Aug 20, 2009
Registry last updated
Aug 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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