Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005603 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for acute lymphoblastic leukemia.
PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study |
Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: Patients are stratified by CNS or testicular disease (yes vs no).
Patients with M1 bone marrow proceed to consolidation therapy. Patients achieving M2 bone marrow on day 29 receive oral prednisone 3 times daily on days 29-42; vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36; and asparaginase IM on days 29, 32, 36, and 39. If bone marrow is M3 on day 29 or M2 on day 43, then patient is off study.
Patients then proceed to interim maintenance and delayed intensification on weeks 15-46. Courses repeat every 16 weeks.
Patients may receive oral methotrexate on day 1 of each course (if IT methotrexate is not administered).
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 3.1 years.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell precursor acute lymphoblastic leukemia
Classified as high risk:
Meets criteria for 1 of the following:
Any age with WBC > 100,000/mm^3
If younger, WBC must be 1 of the following:
At least one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027-0700 | |
Lucile Packard Children's Hospital at Stanford | |
Palo Alto, California, United States, 94304 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0128 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Illinois | |
Saint Jude Midwest Affiliate | |
Peoria, Illinois, United States, 61637 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216-4505 | |
United States, New York | |
Albert Einstein Clinical Cancer Center | |
Bronx, New York, United States, 10461 | |
Herbert Irving Comprehensive Cancer Center | |
New York, New York, United States, 10032 | |
State University of New York - Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, Ohio | |
Children's Hospital Medical Center - Cincinnati | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Oregon | |
Doernbecher Children's Hospital | |
Portland, Oregon, United States, 97201-3098 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555-0361 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 |
Study Chair: | William P. Bowman, MD | Cook Children's Medical Center - Fort Worth |
Study ID Numbers: | CDR0000067722, COG-P9906, POG-9906 |
Study First Received: | May 2, 2000 |
Last Updated: | February 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00005603 History of Changes |
Health Authority: | United States: Federal Government |
childhood acute lymphoblastic leukemia in remission B-cell childhood acute lymphoblastic leukemia |
Anti-Inflammatory Agents Acute Lymphoblastic Leukemia, Childhood Dexamethasone Antimetabolites Daunorubicin Prednisone Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide 6-Mercaptopurine Hormones Anti-Bacterial Agents |
Leukemia Methotrexate Alkylating Agents Lymphoma Dexamethasone acetate Cytarabine Acute Lymphoblastic Leukemia Asparaginase Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Thioguanine Vincristine Antimitotic Agents Folic Acid Antagonists |
Dexamethasone Anti-Inflammatory Agents Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin |