Status:
COMPLETED
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
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Leukemia, Myelocytic, Acute
Eligibility:
All Genders
18-61 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00962767
Start Date
May 1 2002
End Date
December 1 2007
Last Update
August 20 2009
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