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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

Page last updated: August 23, 2015

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