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)
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.
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:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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:
Wyeth is now a wholly owned subsidiary of Pfizer
Italy: Ethics Committee
- Leukemia, Myelocytic, Acute
- Oncology comparison study
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Promyelocytic, Acute