Latest1 information on COVID-19
©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT00551460
S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
Professor of Medicine (Hematology)
Clinical Associate Professor, Medicine - Hematology
Clinical Associate Professor, Medicine - Oncology
Clinical Associate Professor, Medicine - Hematology
DISEASE CHARACTERISTICS:
- Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow
examination
- APL-RARα-negative by RT-PCR are not eligible
- High-risk disease, defined as WBC > 100,000/mm^3
- Bone marrow specimens must be made available for cytogenetic studies
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prolonged QTc > 0.47 sec
- No other malignancy within the past 5 years, except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or stage II cancer from which the patients is currently in complete remission
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for acute leukemia
- At least 3 days since prior tretinoin (ATRA) allowed
- Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts
allowed
drug: arsenic trioxide
drug: gemtuzumab ozogamicin
drug: mercaptopurine
drug: methotrexate
drug: tretinoin
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061