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Sponsored by: |
Prince of Wales Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00707083 |
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. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
Condition | Intervention |
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Leukemia |
Drug: dexamethasone Drug: mercaptopurine Drug: methotrexate Drug: vincristine sulfate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008. |
Estimated Enrollment: | 440 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Standard- or Intermediate-Risk Maintenance Arm I: Active Comparator
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
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Drug: dexamethasone
Given IV
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given orally
Drug: vincristine sulfate
Given IV
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Standard- or Intermediate-Risk Maintenance Arm II: Experimental
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
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Drug: dexamethasone
Given IV
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given orally
Drug: vincristine sulfate
Given IV
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Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia meeting 1 of the following risk definitions:
Standard-risk disease:
None of the following subtypes:
Intermediate-risk disease:
Meets 1 of the following criteria:
High-risk disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
China | |
Prince of Wales Hospital | Recruiting |
Hong Kong, China | |
Contact: Chi-Kong Li, MD 852-2632-1019 | |
Queen Mary Hospital - Hong Kong | Recruiting |
Hong Kong, China | |
Contact: Contact Person 852-2855-3453 |
Principal Investigator: | Chi-Kong Li, MD | Prince of Wales Hospital |
Study ID Numbers: | CDR0000595184, POWH-CRE-2008.077-T |
Study First Received: | June 27, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00707083 |
Health Authority: | Unspecified |
untreated childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia childhood acute lymphoblastic leukemia in remission B-cell childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia |
Dexamethasone Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Vincristine 6-Mercaptopurine Recurrence |
Folic Acid Leukemia Lymphatic Diseases Methotrexate Lymphoproliferative Disorders Lymphoma Dexamethasone acetate |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Hormones Therapeutic Uses Abortifacient Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Tubulin Modulators |