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

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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: Leukemia, Adult Acute Leukemia, Adult Chronic 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
Estimated Study Completion Date:	December 2008
Estimated 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

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

Contacts

Contact: Nicola Goekbugt, MD	49-069-6301-6365	goekbuget@em.uni-frankfurt.de
Contact: Dieter Hoelzer, MD, PhD	49-069-6500-73170	hoelzer@em.uni-frankfurt.de

Locations

Germany
HELIOS Klinikum Berlin-Buch	Recruiting
Berlin, Germany, 13125
Contact: Richard Ratei, MD richard.ratei@helios-kliniken.de
Germany, Baden-Württemberg
Robert Bosch Krankenhaus	Recruiting
Stuttgart, Baden-Württemberg, Germany, 70376
Contact: Lothar Leimer, MD
Contact Lothar.Leimer@bk.de
Germany, Bayern
Klinikum der Universität Regensburg	Recruiting
Regensburg, Bayern, Germany, 93042
Contact: Albrecht Reichle, MD, PhD albrecht.reichle@klinik.uni-regensburg.de
Germany, Hessen
University Hospital of Frankfurt, Medical Dept. II	Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Nicola Goekbuget, MD 49-069-6301-6365 goekbuget@em.uni-frankfurt.de
Sub-Investigator: Nicola Goekbuget, MD
Germany, Niedersachsen
Medizinische Hochschule Hannover	Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Helmut Diedrich, MD diedrich.helmut@mh-hannover.de
Germany, NRW
Universitätsklinikum Essen	Recruiting
Essen, NRW, Germany, 45147
Contact: Andreas Hüttmann, MD haema.studien@uk-essen.de
Universitätsklinik Münster	Recruiting
Münster, NRW, Germany, 48149
Contact: Matthias Stelljes, MD stelljes@uni-muenster.de
Germany, Sachsen
Universitätsklinik Dresden	Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Ralph Naumann, MD ralph.naumann@niklinikum-dresden.de
Universitätsklinikum Leipzig	Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Nadezda Basara, MD, PhD Nadezda.Basara@medizin.uni-leipzig.de
Germany, Schleswig-Holstein
Universitätsklinikum Kiel	Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Andreas Günther, MD a.guenther@ed2.uni-kiel.de
Germany, Thüringen
Klinikum der FSU Jena	Recruiting
Jena, Thüringen, Germany, 07747
Contact: Karin Schrenk, MD karin.schrenk@med.uni-jena.de

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:	University Hospital of Frankfurt ( Dieter Hoelzer, MD, PhD )
Study ID Numbers:	LN_GMALLE_2004_55
Study First Received:	May 16, 2008
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00684619 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders

Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 09, 2009