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Leukemia

Gemtuzumab + Combo Chemotherapy for Previously Untreated APL (SWOG 0535)
A Phase II Study of ATRA, Arsenic Trioxide, and Gemtuzumab Ozogamicin in Patients with Previously Untreated High-Risk Acute Promyelocytic Leukemia
Status Conditions Phase Study ID
Recruiting Acute Promyeloid Leukemia (APL) Phase II SWOG 0535
NCT00551460
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.


Investigator
Fred Appelbaum, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Last Updated
December 21, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.