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

August 16, 2022 updated by: Nicola Goekbuget, Goethe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70376
        • Robert Bosch Krankenhaus
    • Bayern
      • Regensburg, Bayern, Germany, 93042
        • Klinikum der Universität Regensburg
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital of Frankfurt, Medical Dept. II
    • NRW
      • Essen, NRW, Germany, 45147
        • Universitätsklinikum Essen
      • Münster, NRW, Germany, 48149
        • Universitätsklinik Münster
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitatsklinik Dresden
      • Leipzig, Sachsen, Germany, 04103
        • Universitatsklinikum Leipzig
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Kiel
    • Thüringen
      • Jena, Thüringen, Germany, 07747
        • Klinikum der FSU Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
Time Frame: after 1 cycle and 2 cycles
after 1 cycle and 2 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

  • Study Chair: Dieter Hoelzer, MD, PhD, University Hospital of Frankfurt, Medical Dept. II

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LN_GMALLE_2004_55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe