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German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003) | Clinical Trials | Clareo Health

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German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)

NCT00198991•Goethe University

View on ClinicalTrials.gov

Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Eligibility

Age

15 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
•Age 15-65 yrs (\*55-65 years if biologically younger according to general condition)
•Written informed consent

Exclusion Criteria

•Severe comorbidity or leukemia associated complications
•Late relapse of pediatric ALL or ALL as second malignancy
•Cytostatic pre-treatment
•Pregnancy
•Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
•Participation in other clinical trials interfering with the study therapy

Locations (1)

University of Frankfurt, Medical Dept. II

Frankfurt, Germany

Key Dates

Start Date

April 1, 2003

Primary Completion Date

June 30, 2011

Completion Date

June 30, 2013

Last Updated

August 18, 2022

Enrollment

1,883

ACTUAL participants

Conditions

Adult Acute Lymphocytic Leukemia

Interventions

Cyclophosphamide

DRUG

Dexamethasone

DRUG

Vincristine

DRUG

Daunorubicin

DRUG

Asparaginase

DRUG

Methotrexate

DRUG

Cytarabine

DRUG

Mercaptopurine

DRUG

G-CSF

DRUG

Vindesine

DRUG

Etoposide

DRUG

Prednisolone

DRUG

Adriamycin

DRUG

Thioguanine

DRUG

Teniposide

DRUG

CNS irradiation

PROCEDURE

Mediastinal Irradiation

PROCEDURE

Stem cell transplantation (SCT)

PROCEDURE

Idarubicin

DRUG

Fludarabine

DRUG

Cladribine

DRUG

Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma

NCT00199043

Adult Acute Lymphocytic LeukemiaHigh-grade Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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