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COMPLETEDPHASE3

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

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)

NCT00962767•Wyeth is now a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 61 years

Sex

ALL

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.

Key Dates

Start Date

May 1, 2002

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

August 20, 2009

Enrollment

168

ACTUAL participants

Conditions

Leukemia, Myelocytic, Acute

Interventions

gemtuzumab ozogamicin

DRUG

ATRA plus 6-MP and MTX

DRUG

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

NCT02158858

MyelofibrosisLeukemia, Myelocytic, Acute+12 more

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COMPLETEDPHASE2

Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)

NCT00201240

Leukemia, Myelocytic, Acute

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)

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