Status:
COMPLETED
ALL-REZ BFM 2002: Multi-Center Study for Children With Relapsed Acute Lymphoblastic Leukemia
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Deutsche Kinderkrebsstiftung
Conditions:
Lymphoblastic Leukemia, Acute
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
The protocol ALL-REZ BFM 2002 aims at the optimization of treatment for children with relapsed acute lymphoblastic leukemia. The primary objective of study ALL-REZ BFM 2002 is the randomized compariso...
Detailed Description
The study is based on the results of five consecutive trials performed by the ALL-REZ BFM study group since 1983. Thus the study meets the criteria of evidence-based therapy, which has been developed ...
Eligibility Criteria
Inclusion
- Up to 18 years of age
- Morphologically confirmed diagnosis of relapsed non-B ALL or non-B non-Hodgkin lymphoma
Exclusion
- They have completed the 18th year of life at the time the relapse is diagnosed.
- Curative therapy is declined either by patient himself/herself or the respective legal guardian
- The patient is pregnant
- The patient is breast feeding
- Essential parts of the relapse therapy are declined either by the patient or his/her legal cannot be administered because of medical reasons.
- No consent is given for transmission of data
- The patient has a severe concomitant disease that does not allow treatment according to protocol (e.g. malformation syndromes, cardiac malformations, metabolic disorders).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00114348
Start Date
August 1 2003
End Date
July 1 2012
Last Update
February 4 2013
Active Locations (1)
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1
ALL-REZ Studienzentrale
Berlin, State of Berlin, Germany, 13353