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Leukemia

Combination Chemotherapy for Young Patients With Newly Diagnosed T-Cell ALL (COG AALL0434)
Intensified Methotrexate, Nelarabine (Compound 506U78 IND # 52611) and Augmented BFM Therapy in Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia
Status Conditions Phase Study ID
Recruiting Acute Lymphoid Leukemia (ALL) Phase III COG AALL0434
NCT00408005
Summary

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.


Investigator
Blythe Thomson, MD
Location    
Seattle Children's 206-884-5184  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Last Updated
February 02, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.