Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Oncology | Hematology
Disease Category: Leukemia

Trial Information

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia COG AALL0434

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 T-cell acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia.

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Newly diagnosed T-cell acute lymphoblastic leukemia, meeting the following criteria:
  • Leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (CD19/CD22/CD20) AND express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a
• If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34, or CD99 will be assessed for expression
• Concurrently enrolled on protocol COG-AALL03B1

PATIENT CHARACTERISTICS:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No peripheral neurotoxicity ≥ grade 2 (for patients randomized to receive nelarabine)
• No prior seizure disorder (for patients randomized to receive nelarabine

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior steroid therapy allowed
• No prior cytotoxic chemotherapy except intrathecal cytarabine
• At least 2 years since prior and no concurrent anticonvulsant therapy (for patients randomized to receive nelarabine)
• No concurrent milk or citrus products during thioguanine or mercaptopurine administration
• No concurrent intensity-modulated radiotherapy
• No concurrent nonsteroidal anti-inflammatory drugs, penicillin, or acetylsalicyclic acid-containing medications for at least 3 days after high-dose methotrexate

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

View Google Map

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.