506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Information source: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: T-ALL, T-NHL (Lymphoblastic)
Intervention: Nelarabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Johann Wolfgang Goethe University Hospitals Official(s) and/or principal investigator(s): Dieter Hoelzer, MD, PhD, Study Chair, Affiliation: University Hospital of Frankfurt, Medical Dept. II
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 transplantation.
Clinical Details
Official title: Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
HELIOS Klinikum Berlin-Buch, Berlin 13125, Germany
Robert Bosch Krankenhaus, Stuttgart, Baden-Württemberg 70376, Germany
Klinikum der Universität Regensburg, Regensburg, Bayern 93042, Germany
University Hospital of Frankfurt, Medical Dept. II, Frankfurt, Hessen 60590, Germany
Universitätsklinikum Essen, Essen, NRW 45147, Germany
Universitätsklinik Münster, Münster, NRW 48149, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen 30625, Germany
Universitätsklinik Dresden, Dresden, Sachsen 01307, Germany
Universitätsklinikum Leipzig, Leipzig, Sachsen 04103, Germany
Universitätsklinikum Kiel, Kiel, Schleswig-Holstein 24105, Germany
Klinikum der FSU Jena, Jena, Thüringen 07747, Germany
Additional Information
Starting date: June 2003
Last updated: August 20, 2010
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