Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia
NCT ID: NCT00276601
Last Updated: 2014-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2004-10-31
2013-06-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia.
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Detailed Description
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* Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by tretinoin maintenance therapy in patients receiving induction tretinoin and daunorubicin hydrochloride with acute promyelocytic leukemia (APL) induced into remission with tretinoin and daunorubicin hydrochloride.
* Determine, preliminarily, the efficacy of this strategy in inducing and maintaining molecular remissions in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
* Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days 60-67 and proceed to consolidation therapy.
* Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3, daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with clinical and/or cytogenic, but not molecular, remission receive additional arsenic trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed to maintenance therapy.
* Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment repeats every 3 months for 8 courses (2 years).
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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arsenic trioxide
cytarabine
daunorubicin hydrochloride
mercaptopurine
methotrexate
tretinoin
Eligibility Criteria
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Inclusion Criteria
* Patients found to have cytogenetic abnormalities that do not produce the PML-RARĪ± gene rearrangement will be removed from study and will not be included in data analysis
PATIENT CHARACTERISTICS:
* Patients will not be excluded because of performance status or comorbid disease
* Premenopausal female patients must have a negative pregnancy test
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for APL except hydroxyurea
5 Years
74 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigators
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Steven D. Gore, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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JHOC-J0442
Identifier Type: -
Identifier Source: secondary_id
WIRB-20041058
Identifier Type: -
Identifier Source: secondary_id
J0442, CDR0000449985
Identifier Type: -
Identifier Source: org_study_id
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