Risk-Adapted Chemotherapy for Young Patients with Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01190930

Provider View

This study is testing different chemotherapy combinations to see how well they work and what side effects they have in young patients with newly diagnosed standard-risk acute lymphoblastic leukemia or localized B-lineage lymphoblastic lymphoma.

Patient Parameters

Program Overview

This clinical trial is exploring how different combinations of chemotherapy drugs can treat young patients with newly diagnosed standard-risk acute lymphoblastic leukemia (ALL) or localized B-lineage lymphoblastic lymphoma (B-LLy). The study aims to find the best way to stop cancer cells from growing by using various drugs that work in different ways. By combining these drugs in different doses and combinations, researchers hope to kill more cancer cells and improve treatment outcomes.

Description

The main goals of this study are to:

  1. See if a higher dose of methotrexate taken weekly can improve disease-free survival compared to a lower dose in patients with average-risk B-precursor ALL.
  2. Determine if reducing the frequency of vincristine and dexamethasone pulses to every 12 weeks affects disease-free survival compared to every 4 weeks in average-risk patients.
  3. Confirm that low-risk patients can achieve a 5-year disease-free survival rate of at least 95% with specific treatment regimens.
  4. Provide standardized treatment and support for children with Down syndrome and standard-risk B-ALL to improve outcomes.
  5. Improve understanding of the biology of localized B-LLy and Down syndrome B-LLy by collecting biological data and tissue samples for future research.
  6. Describe the 5-year event-free and overall survival rates for patients with certain stages of B-LLy receiving modified therapy.

The study also aims to assess the impact of therapy on quality of life, family functioning, and emotional distress, as well as to understand the onset and severity of vincristine-associated neuropathy.

Patients will receive various chemotherapy drugs in different phases, including induction, consolidation, interim maintenance, delayed intensification, and maintenance therapy. The treatment plan varies based on risk level and includes drugs like vincristine, dexamethasone, methotrexate, and others. Patients with specific conditions may be eligible for different treatment arms or transferred to other trials based on their risk level and response to initial therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in specific studies for classification of newly diagnosed ALL patients.
  • Initial white blood cell count must be less than 50,000/uL.
  • Must have newly diagnosed standard-risk B-ALL or B-LLy at certain stages; patients with Down syndrome are eligible.
  • All patients and their guardians must sign a written informed consent.
  • Must meet all institutional, FDA, and NCI requirements for human studies.

Exclusion Criteria

  • Must not have received prior cytotoxic chemotherapy for the current diagnosis or any previous cancer, except for certain pre-treatments.
  • Must not have central nervous system 3 (CNS3) leukemia.
  • B-ALL patients with testicular leukemia are not eligible.
  • B-LLy patients must not have certain types of lymphoma or specific disease characteristics.
  • Female patients who are pregnant or breastfeeding are not eligible.
  • Sexually active patients must agree to use effective contraception during the study.

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