Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
T-ALL, T-NHL (Lymphoblastic)
Both
T-ALL, T-NHL (Lymphoblastic)
Trial Information
Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
Inclusion Criteria:
- 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 Criteria:
- Severe psychiatric illness
- uncontrolled or severe cardiac disease or infection
- active secondary neoplasms - except skin cancer (no melanoma)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
Outcome Time Frame:
after 1 cycle and 2 cycles
Safety Issue:
Yes
Principal Investigator
Dieter Hoelzer, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital of Frankfurt, Medical Dept. II
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
LN_GMALLE_2004_55
NCT ID:
NCT00684619
Start Date:
June 2003
Completion Date:
December 2008
Related Keywords:
- T-ALL, T-NHL (Lymphoblastic)
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia-Lymphoma, Adult T-Cell
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
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