506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

Phase 2

Completed

• Conditions: T-ALL, T-NHL (Lymphoblastic)
• Interventions: Drug: Nelarabine

• Registration Number: NCT00684619
• Lead Sponsor: Goethe University

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 transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Nelarabine	Nelarabine

Primary Outcome Measures

Name	Time	Method
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL	after 1 cycle and 2 cycles

Trial Locations

Locations (11)

Universitätsklinikum Essen; 🇩🇪 Essen, NRW, Germany

Robert Bosch Krankenhaus; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

University Hospital of Frankfurt, Medical Dept. II; 🇩🇪 Frankfurt, Hessen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Klinikum der Universität Regensburg; 🇩🇪 Regensburg, Bayern, Germany

Universitätsklinik Münster; 🇩🇪 Münster, NRW, Germany

Universitätsklinik Dresden; 🇩🇪 Dresden, Sachsen, Germany

Universitätsklinikum Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Klinikum der FSU Jena; 🇩🇪 Jena, Thüringen, Germany

HELIOS Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany