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

This study has been completed.

First Received on May 16, 2008. Last Updated on August 20, 2010 History of Changes

Sponsor:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00684619

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 II

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia Lymphoma

Drug Information available for: Nelarabine

U.S. FDA Resources

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:

1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5

Other Names:

Compound 506U78
Atriance
Arranon

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Investigators

Study Chair:

Dieter Hoelzer, MD, PhD

University Hospital of Frankfurt, Medical Dept. II

More Information

Additional Information:

European Leukemia Trial Registry This link exits the ClinicalTrials.gov site

German Leukemia Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia-Lymphoma, Adult T-Cell
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type

Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, T-Cell

ClinicalTrials.gov processed this record on February 12, 2012