Overview

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

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
6-Mercaptopurine
Arsenic Trioxide
Gemtuzumab
Mercaptopurine
Methotrexate
Tretinoin
Criteria
DISEASE CHARACTERISTICS:

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

- APL-RARĪ±-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