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

This study has been completed.
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
First received: May 16, 2008
Last updated: August 20, 2010
Last verified: May 2008
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.

Condition Intervention Phase
T-ALL, T-NHL (Lymphoblastic)
Drug: Nelarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)

Resource links provided by NLM:

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL [ Time Frame: after 1 cycle and 2 cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: June 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nelarabine
    1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
    Other Names:
    • Compound 506U78
    • Atriance
    • Arranon

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00684619

Robert Bosch Krankenhaus
Stuttgart, Baden-Württemberg, Germany, 70376
Klinikum der Universität Regensburg
Regensburg, Bayern, Germany, 93042
University Hospital of Frankfurt, Medical Dept. II
Frankfurt, Hessen, Germany, 60590
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Universitätsklinikum Essen
Essen, NRW, Germany, 45147
Universitätsklinik Münster
Münster, NRW, Germany, 48149
Universitätsklinik Dresden
Dresden, Sachsen, Germany, 01307
Universitätsklinikum Leipzig
Leipzig, Sachsen, Germany, 04103
Universitätsklinikum Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Klinikum der FSU Jena
Jena, Thüringen, Germany, 07747
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Study Chair: Dieter Hoelzer, MD, PhD University Hospital of Frankfurt, Medical Dept. II
  More Information

Additional Information:
Responsible Party: Dieter Hoelzer, MD, PhD, University Hospital of Frankfurt
ClinicalTrials.gov Identifier: NCT00684619     History of Changes
Other Study ID Numbers: LN_GMALLE_2004_55 
Study First Received: May 16, 2008
Last Updated: August 20, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 22, 2016