German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

March 16, 2023 updated by: Nicola Goekbuget, Goethe University

Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)

The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

377

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 Contact

Study Contact Backup

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • University of Frankfurt, 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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
  • Age > 55 yrs (no upper age limit)
  • Written informed consent

Exclusion Criteria:

  • Severe leukemia associated complications, not controllable before therapy onset e.g.
  • life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
  • Severe comorbidity e.g.
  • decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
  • heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
  • hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin > 1,5 x ULN and/or ASA, ALA, AP > 2,5 ULN
  • decompensated metabolic disturbances (e.g. not controllable diabetes)
  • severe obstructive or restrictive pulmonary disease with hypoxaemia
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Active second neoplasia
  • HIV infection
  • Severely reduced general condition
  • Cytostatic pre-treatment of ALL
  • Chemotherapy treatment of any other malignancy during the last 5 years
  • Participation in other clinical trials interfering with the study therapy

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: Interventional arm
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Rituximab
Drug: Cytarabine
Drug: Mercaptopurine
Drug: Dexamethasone / Prednisolone
Drug: Asparaginase
Drug: Idarubicin
Drug: HDARAC
Drug: Granulocyte-Colony-Stimulating Factor
Drug: Depocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission rate (cytologic, molecular)
Time Frame: After induction; approximately 6 wks (exact time frame not specified)
After induction; approximately 6 wks (exact time frame not specified)
Toxicity (CTC)
Time Frame: After each cycle; time-frame not specified
After each cycle; time-frame not specified
Survival time, Duration of Remission
Time Frame: at 3 and 5 years
at 3 and 5 years

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 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

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)

January 1, 2003

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2014

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 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMALL02

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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