506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Information source: Johann Wolfgang Goethe University Hospitals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: T-ALL, T-NHL (Lymphoblastic)
Intervention: Nelarabine (Drug)
Phase: Phase 2
Status: Recruiting
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
Overall contact:
Nicola Goekbugt, MD, Phone: 49-069-6301-6365, Email: goekbuget@em.uni-frankfurt.de
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
Nicola Goekbugt, MD, Phone: 49-069-6301-6365, Email: goekbuget@em.uni-frankfurt.de
HELIOS Klinikum Berlin-Buch, Berlin 13125, Germany; Recruiting
Richard Ratei, MD, Email: richard.ratei@helios-kliniken.de
Robert Bosch Krankenhaus, Stuttgart, Baden-Württemberg 70376, Germany; Recruiting
Lothar Leimer, MD
Email: Lothar.Leimer@bk.de
Klinikum der Universität Regensburg, Regensburg, Bayern 93042, Germany; Recruiting
Albrecht Reichle, MD, PhD, Email: albrecht.reichle@klinik.uni-regensburg.de
University Hospital of Frankfurt, Medical Dept. II, Frankfurt, Hessen 60590, Germany; Recruiting
Nicola Goekbuget, MD, Phone: 49-069-6301-6365, Email: goekbuget@em.uni-frankfurt.de
Nicola Goekbuget, MD, Sub-Investigator
Universitätsklinikum Essen, Essen, NRW 45147, Germany; Recruiting
Andreas Hüttmann, MD, Email: haema.studien@uk-essen.de
Universitätsklinik Münster, Münster, NRW 48149, Germany; Recruiting
Matthias Stelljes, MD, Email: stelljes@uni-muenster.de
Medizinische Hochschule Hannover, Hannover, Niedersachsen 30625, Germany; Recruiting
Helmut Diedrich, MD, Email: diedrich.helmut@mh-hannover.de
Universitätsklinik Dresden, Dresden, Sachsen 01307, Germany; Recruiting
Ralph Naumann, MD, Email: ralph.naumann@niklinikum-dresden.de
Universitätsklinikum Leipzig, Leipzig, Sachsen 04103, Germany; Recruiting
Nadezda Basara, MD, PhD, Email: Nadezda.Basara@medizin.uni-leipzig.de
Universitätsklinikum Kiel, Kiel, Schleswig-Holstein 24105, Germany; Recruiting
Andreas Günther, MD, Email: a.guenther@ed2.uni-kiel.de
Klinikum der FSU Jena, Jena, Thüringen 07747, Germany; Recruiting
Karin Schrenk, MD, Email: karin.schrenk@med.uni-jena.de
Additional Information
European Leukemia Trial Registry German Leukemia Trial Registry
Starting date: June 2003
Ending date: December 2008
Last updated: May 23, 2008
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