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)
Phase 3
18 Years
61 Years
18 Years
61 Years
Not Enrolling
Both
Leukemia, Myelocytic, Acute
Both
Leukemia, Myelocytic, Acute
Trial Information
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)
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
Italy: Ethics Committee
Study ID:
0903X-101128
NCT ID:
NCT00962767
Start Date:
May 2002
Completion Date:
December 2007
Related Keywords:
- Leukemia, Myelocytic, Acute
- Oncology comparison study
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Promyelocytic, Acute
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