German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

March 15, 2023 updated by: Nicola Goekbuget, Goethe University

Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)

The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

720

Phase

  • Phase 4

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
      • Frankfurt, Germany
        • University Hospital, Medical Dept. II

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

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute Lymphocytic Leukemia
  • Age 15 - 65 years

Exclusion Criteria:

  • Serious secondary diseases which may compromise intensified chemotherapeutical treatment
  • Serious psychiatric diseases, which may compromise compliance with therapy
  • HIV-1 or HIV-2 Infection
  • Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
  • Patients without central diagnosis who cannot be allocated to a risk group

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
remission rate, disease free survival, overall survival

Secondary Outcome Measures

Outcome Measure
death in induction, toxicity, time and dose compliance

Collaborators and Investigators

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

Sponsor

Goethe University

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

  • Study Chair: Dieter Hoelzer, MD, PhD, University of Frankfurt, Medical Department 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.

Helpful Links

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 (Actual)

April 1, 1993

Primary Completion (Actual)

January 1, 1999

Study Completion (Actual)

May 1, 2001

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMALL09

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.

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