S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Not Recruiting

Trial ID: NCT00551460


RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.

Official Title

S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Stanford Investigator(s)

Jason Gotlib

Professor of Medicine (Hematology)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology



   - Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow

      - 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


   - 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


   - 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


drug: arsenic trioxide

drug: gemtuzumab ozogamicin

drug: mercaptopurine

drug: methotrexate

drug: tretinoin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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