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Study 8 of 344 for search of: | Canada, New Brunswick |
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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group National Cancer Institute of Canada Southwest Oncology Group Children's Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003934 |
RATIONALE: Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate, and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It is not yet known which regimen is more effective for acute promyelocytic leukemia.
PURPOSE: This randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: arsenic trioxide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: tretinoin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (As2O3) (NSC# 706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients With Untreated Acute Promyelocytic Leukemia |
Estimated Enrollment: | 522 |
Study Start Date: | June 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 15 vs 15 to 60 vs over 60) for the induction phase. Patients are stratified according to age, as in the induction phase, and the consolidation arm (with vs without arsenic trioxide) for the consolidation phase. Patients under age 5 do not receive arsenic trioxide.
Consolidation: All patients achieving complete response (CR), or partial response (PR) after completion of tretinoin, proceed to consolidation within 2 weeks of achieving CR or PR, but not prior to 30 days from the start of induction. Patients are randomized to 1 of 2 treatment arms.
Maintenance: Patients maintaining CR or PR after consolidation therapy proceed to maintenance therapy, beginning no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery. Patients are randomized to 1 of 2 treatment arms.
Maintenance therapy continues for up to 1 year in the absence of unacceptable toxicity.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 522 patients (456 adults and 66 pediatric) will be accrued for this study within 4.75 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically diagnosed, previously untreated acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by reverse transcriptase polymerase chain reaction
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Bayard L. Powell, MD | Wake Forest University |
Study Chair: | Martin S. Tallman, MD | Robert H. Lurie Cancer Center |
Study Chair: | Stephen Couban, MD | Cancer Care Nova Scotia |
Study Chair: | Steven E. Coutre, MD | Stanford University |
Study Chair: | Bayard L. Powell, MD | Wake Forest University |
Study ID Numbers: | CDR0000067126, CALGB-C9710, CAN-NCIC-AL3, COG-C9710, ECOG-C9710, SWOG-C9710, CAN-NCIC-C9710 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003934 |
Health Authority: | United States: Federal Government |
untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies adult acute promyelocytic leukemia (M3) childhood acute promyelocytic leukemia (M3) adult acute myeloid leukemia with t(15;17)(q22;q12) |
Daunorubicin Myeloproliferative Disorders Acute myelogenous leukemia Acute promyelocytic leukemia Arsenic trioxide Leukemia, Myeloid 6-Mercaptopurine Leukemia, Myeloid, Acute |
Folic Acid Leukemia Leukemia, Promyelocytic, Acute Tretinoin Methotrexate Acute myeloid leukemia, adult Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Keratolytic Agents Neoplasms Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |