Clinical Trial: Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

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

Official Title: Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence

Brief Summary:

RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the growth of cancer cells and the patient's immune system from rejecting the stem cells. When the stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and total-body irradiation followed by a stem cell transplant may be an effective treatment for anaplastic large cell lymphoma.

PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma.


Detailed Summary:

OBJECTIVES:

Primary

  • Improve the probability of event-free survival in children and adolescents with early progression of anaplastic large cell lymphoma (ALCL) and/or relapse of ALCL with CD3-positive immunophenotype treated with reinduction combination chemotherapy followed by allogeneic or autologous stem cell transplantation.
  • Determine whether a conditioning regimen comprising carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM) (without total body irradiation) for autologous stem cell transplantation is an effective treatment for patients with relapsed CD3-negative ALCL occurring after the intensive phase of treatment.
  • Determine the impact of vinblastine in patients with late relapse of CD3-negative ALCL who have not received vinblastine during frontline therapy.

Secondary

  • Determine overall survival and treatment-related mortality in patients treated with these regimens.
  • Determine acute and long-term toxicity in patients treated with these regimens.
  • Determine the rate of acute and chronic graft-vs-host disease in patients treated with allogeneic stem cell transplantation.

OUTLINE: This is a multicenter, prospective, nonrandomized study. Patients are stratified according to time from initial diagnosis to progression/relapse, immunophenotype of lymphoma cells (CD3-positive + vs CD3-negative), stem cell donor availability (matched sibling donor vs 9/10 or 10/10 matched unrelated donor), and vinblastine during frontline therapy (yes vs no).

    Sponsor: European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma

    Current Primary Outcome: Event-free survival as measured by the Kaplan-Meier method

    Original Primary Outcome:

    Current Secondary Outcome:

    • Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria
    • Overall survival
    • Acute and long term toxicity
    • Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation
    • Treatment related mortality


    Original Secondary Outcome:

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: April 19, 2006
    Date Started: April 2004
    Date Completion:
    Last Updated: September 24, 2015
    Last Verified: September 2015