506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
NCT ID: NCT00684619
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2003-06-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Nelarabine
Nelarabine
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
Interventions
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Nelarabine
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* uncontrolled or severe cardiac disease or infection
* active secondary neoplasms - except skin cancer (no melanoma)
18 Years
ALL
No
Sponsors
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Goethe University
OTHER
Responsible Party
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Nicola Goekbuget
GMALL Head
Principal Investigators
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Dieter Hoelzer, MD, PhD
Role: STUDY_CHAIR
University Hospital of Frankfurt, Medical Dept. II
Locations
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Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Klinikum der Universität Regensburg
Regensburg, Bavaria, Germany
University Hospital of Frankfurt, Medical Dept. II
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinik Münster
Münster, North Rhine-Westphalia, Germany
Universitätsklinik Dresden
Dresden, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitätsklinikum Kiel
Kiel, Schleswig-Holstein, Germany
Klinikum der FSU Jena
Jena, Thuringia, Germany
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Countries
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References
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Gokbuget N, Basara N, Baurmann H, Beck J, Bruggemann M, Diedrich H, Guldenzoph B, Hartung G, Horst HA, Huttmann A, Kobbe G, Naumann R, Ratei R, Reichle A, Serve H, Stelljes M, Viardot A, Wattad M, Hoelzer D. High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation. Blood. 2011 Sep 29;118(13):3504-11. doi: 10.1182/blood-2011-01-329441. Epub 2011 Jun 28.
Other Identifiers
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LN_GMALLE_2004_55
Identifier Type: -
Identifier Source: org_study_id
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