Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684619
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
Nicola Goekbuget, Goethe University

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
T-ALL, T-NHL (Lymphoblastic) Drug: Nelarabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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 : June 2003
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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

Primary Outcome Measures :
  1. Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL [ Time Frame: after 1 cycle and 2 cycles ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00684619

Layout table for location information
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
Goethe University
Layout table for investigator information
Study Chair: Dieter Hoelzer, MD, PhD University Hospital of Frankfurt, Medical Dept. II

Layout table for additonal information
Responsible Party: Nicola Goekbuget, GMALL Head, Goethe University Identifier: NCT00684619     History of Changes
Other Study ID Numbers: LN_GMALLE_2004_55
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases