Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma | Not Recruiting
Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma
Health Conditions
  • Lymphoma
Not Recruiting
Recruitment Status
NCT00317408
Primary Trial ID Number
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.
Primary Outcome Measures
  • Event-free survival as measured by the Kaplan-Meier method; null
Secondary Outcome Measures
  • Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria; null; Overall survival; null; Acute and long term toxicity; null; Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation; null; Treatment related mortality; null
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
Austria; Belgium; Czech Republic; France; Germany; Ireland; Italy; Netherlands; Poland; Sweden; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
N/A to 21 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
96
Participant Inclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL)
  • - Progressive disease OR first relapse
  • - No second or subsequent relapse of ALCL
  • - Slides available for national central pathology review
  • - Availability of 1 of the following (for allogeneic stem cell transplantation only):
  • - HLA-identical matched sibling donor
  • - 10/10 HLA-matched nonsibling donor (related or unrelated)
  • - 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated
  • donor)
  • - < 9/10 HLA-mismatched donor (related or unrelated)
  • - Stem cells may be obtained from unmanipulated bone marrow or peripheral
  • blood stem cells after filgrastim (G-CSF) stimulation
  • PATIENT CHARACTERISTICS:
  • - Not pregnant or nursing
  • - Negative pregnancy test
  • - Fertile patients must use effective contraception
  • - Adequate hepatic, renal, and cardiac function
  • - No HIV infection or AIDS
  • - No severe immunodeficiency
  • - No other prior malignancy
  • - No pre-existing disease or condition prohibiting study treatment
  • PRIOR CONCURRENT THERAPY:
  • - At least 2 months since prior chemotherapy or radiotherapy
  • - No significant pretreatment for first relapse
  • - No prior organ transplantation
  • - No concurrent participation in another clinical trial
Participant Exclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL)
  • - Progressive disease OR first relapse
  • - No second or subsequent relapse of ALCL
  • - Slides available for national central pathology review
  • - Availability of 1 of the following (for allogeneic stem cell transplantation only):
  • - HLA-identical matched sibling donor
  • - 10/10 HLA-matched nonsibling donor (related or unrelated)
  • - 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated
  • donor)
  • - < 9/10 HLA-mismatched donor (related or unrelated)
  • - Stem cells may be obtained from unmanipulated bone marrow or peripheral
  • blood stem cells after filgrastim (G-CSF) stimulation
  • PATIENT CHARACTERISTICS:
  • - Not pregnant or nursing
  • - Negative pregnancy test
  • - Fertile patients must use effective contraception
  • - Adequate hepatic, renal, and cardiac function
  • - No HIV infection or AIDS
  • - No severe immunodeficiency
  • - No other prior malignancy
  • - No pre-existing disease or condition prohibiting study treatment
  • PRIOR CONCURRENT THERAPY:
  • - At least 2 months since prior chemotherapy or radiotherapy
  • - No significant pretreatment for first relapse
  • - No prior organ transplantation
  • - No concurrent participation in another clinical trial
Interventions
Biological; anti-thymocyte globulin; null; []; Drug; busulfan; null; []; Drug; carboplatin; null; []; Drug; carmustine; null; []; Drug; cyclosporine; null; []; Drug; cytarabine; null; []; Drug; dexamethasone; null; []; Drug; etoposide phosphate; null; []; Drug; idarubicin; null; []; Drug; ifosfamide; null; []; Drug; leucovorin calcium; null; []; Drug; lomustine; null; []; Drug; melphalan; null; []; Drug; methotrexate; null; []; Drug; mitoxantrone hydrochloride; null; []; Drug; prednisolone; null; []; Drug; thiotepa; null; []; Drug; vinblastine sulfate; null; []; Drug; vindesine; null; []; Procedure; allogeneic hematopoietic stem cell transplantation; null; []; Procedure; autologous hematopoietic stem cell transplantation; null; []; Procedure; peripheral blood stem cell transplantation; null; []; Radiation; total-body irradiation; null; []
Design Details
Sorry, this information is not available
Study Design
Allocation: Non-Randomized, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence
Secondary Trial Identifying Number
EICNHL-ALCL-RELAPSE; AIEOP-EICNHL-ALCL-RELAPSE; BFM-EICNHL-ALCL-RELAPSE; BSPHO-EICNHL-ALCL-RELAPSE; DCOG-EICNHL-ALCL-RELAPSE; NOPHO-EICNHL-ALCL-RELAPSE; PPLLSG-EICNHL-ALCL-RELAPSE; SFCE-EICNHL-ALCL-RELAPSE; SHOP-EICNHL-ALCL-RELAPSE; CCLG-NHL-2006-01; EU-205118; EU-20618; EUDRACT-2005-003321-57
Website
http://cancer.gov/clinicaltrials/EICNHL-ALCL-RELAPSE
Study Funded By
European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma
Funder Type
Sorry, this information is not available
Study Sponsored By
European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

19 Apr 2006

Last Updated

16 Sep 2013

Date Record Refreshed on UKCTG

31 Jul 2015