Status:
COMPLETED
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Lead Sponsor:
Goethe University
Conditions:
T-ALL, T-NHL (Lymphoblastic)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Nelarabine is effective in the treatment of patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem cell transplant...
Eligibility Criteria
Inclusion
- T-ALL; T-NHL
- age \>= 18 years
- cytological treatment failure / relapse
- molecular treatment failure / relapse
- no promising therapy alternatives with approved medication available
- no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
- no convulsive disease or neurotoxicity \> grade III in patients history
- written informed consent
- no cytostatic therapy in the last 10 days
- no pregnancy or breastfeeding
- effective contraception
- recovery of toxicities of previous chemotherapy - except leukemia- related changes like bone marrow suppression or pathological transaminases in liver manifestation
Exclusion
- Severe psychiatric illness
- uncontrolled or severe cardiac disease or infection
- active secondary neoplasms - except skin cancer (no melanoma)
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00684619
Start Date
June 1 2003
End Date
December 1 2008
Last Update
August 18 2022
Active Locations (11)
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1
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany, 70376
2
Klinikum der Universität Regensburg
Regensburg, Bavaria, Germany, 93042
3
University Hospital of Frankfurt, Medical Dept. II
Frankfurt am Main, Hesse, Germany, 60590
4
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625