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

Sponsor
Goethe University (Other)
Overall Status
Completed
CT.gov ID
NCT00684619
Collaborator
(none)
120
Enrollment
11
Locations
1
Arm
66
Duration (Months)
10.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
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)
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Nelarabine

Drug: Nelarabine
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
Other Names:
  • Compound 506U78
  • Atriance
  • Arranon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL [after 1 cycle and 2 cycles]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert Bosch Krankenhaus Stuttgart Baden-Württemberg Germany 70376
    2 Klinikum der Universität Regensburg Regensburg Bayern Germany 93042
    3 University Hospital of Frankfurt, Medical Dept. II Frankfurt Hessen Germany 60590
    4 Medizinische Hochschule Hannover Hannover Niedersachsen Germany 30625
    5 Universitätsklinikum Essen Essen NRW Germany 45147
    6 Universitätsklinik Münster Münster NRW Germany 48149
    7 Universitätsklinik Dresden Dresden Sachsen Germany 01307
    8 Universitätsklinikum Leipzig Leipzig Sachsen Germany 04103
    9 Universitätsklinikum Kiel Kiel Schleswig-Holstein Germany 24105
    10 Klinikum der FSU Jena Jena Thüringen Germany 07747
    11 HELIOS Klinikum Berlin-Buch Berlin Germany 13125

    Sponsors and Collaborators

    • Goethe University

    Investigators

    • Study Chair: Dieter Hoelzer, MD, PhD, University Hospital of Frankfurt, Medical Dept. II

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicola Goekbuget, GMALL Head, Goethe University
    ClinicalTrials.gov Identifier:
    NCT00684619
    Other Study ID Numbers:
    • LN_GMALLE_2004_55
    First Posted:
    May 26, 2008
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

    Study Results

    No Results Posted as of Aug 18, 2022