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

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

May 23, 2008

Start Date ^ICMJE

June 2003

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00684619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-Lymphoblastic Lymphoma (Amend.7)

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

T-ALL, T-NHL (Lymphoblastic)

Intervention ^ICMJE

Drug: Nelarabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00684619

Responsible Party

Dieter Hoelzer, MD, PhD, University Hospital of Frankfurt

Study ID Numbers ^ICMJE

LN_GMALLE_2004_55

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Dieter Hoelzer, MD, PhD

University Hospital of Frankfurt, Medical Dept. II

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP