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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684619
First Posted: May 26, 2008
Last Update Posted: August 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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 Hospital:

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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


Locations
Germany
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 Hospital
Investigators
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
First Submitted: May 16, 2008
First Posted: May 26, 2008
Last Update Posted: August 23, 2010
Last Verified: May 2008

Additional relevant MeSH terms:
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases