Status:
UNKNOWN
Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma
Lead Sponsor:
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
Conditions:
Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
NA
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 cel...
Detailed Description
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-posit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00317408
Start Date
April 1 2004
Last Update
September 25 2015
Active Locations (98)
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1
St. Anna Children's Hospital
Vienna, Austria, A-1090
2
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
3
University Hospital Brno
Brno, Czechia, CZ-662 63
4
Charles University Hospital
Prague, Czechia, CZ-150 06