Clinical Trial: Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating anaplastic large cell lymphoma.

PURPOSE: This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma.


Detailed Summary:

OBJECTIVES:

  • Compare the event-free survival in children with anaplastic large cell lymphoma treated with various induction and maintenance chemotherapy regimens with or without vinblastine.
  • Compare the impact of different doses and schedules of methotrexate from the Berlin-Frankfurt-Munster-K2 Protocol in terms of overall survival, complete remission rate, CNS relapse rate, and nonlymphoma-related death and early death rates in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to country, vinblastine (VBL) (yes vs no), and prognostic factors (standard-risk (SR) vs high-risk (HR) disease).

Beginning immediately after confirmation of diagnosis, patients receive prephase therapy comprising dexamethasone (DM) IV or orally daily on days 1 and 2 and every 12 hours on days 3-5; cyclophosphamide (CTX) IV over 1 hour on days 1 and 2; and methotrexate (MTX) intrathecally (IT), doxorubicin (DOX) IV, and hydrocortisone (HC) IT on day 1.

Patients are then assigned to one of two treatment groups based on prognosis:

  • Group 1 (SR disease): Patients are randomized to arm I or III:

    • Arm I: Patients receive treatment on arm I as defined below on day 1, and then the following courses as defined below in the following order beginning on day 6: A1, B1, A2, B2, A3, and B3.
    • Arm III: Patients receive treatment on arm III as defined below on day 1, and then the following courses as defined
      Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

      Current Primary Outcome: Event-free survival

      Original Primary Outcome:

      Current Secondary Outcome:

      • Overall survival
      • Complete remission achieved after treatment course B3 and lasting ≥ 4 weeks
      • Short- and long-term toxicity
      • Nonlymphoma related death and early deaths (excluding deaths occurring after second-line treatment for failure or relapse)
      • CNS relapses


      Original Secondary Outcome:

      Information By: National Cancer Institute (NCI)

      Dates:
      Date Received: November 6, 2000
      Date Started: December 1999
      Date Completion:
      Last Updated: August 25, 2011
      Last Verified: August 2011