NCT00198991

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,883 (actual)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cytostatic drug
DRUG	Dexamethasone	Antileukemic drug
DRUG	Vincristine	Cytostatic drug
DRUG	Daunorubicin	Cytostatic drug
DRUG	Asparaginase	Cytostatic drug
DRUG	Methotrexate	Cytostatic drug
DRUG	Cytarabine	Cytostatic drug
DRUG	Mercaptopurine	Cytostatic drug
DRUG	G-CSF	Growth factor
DRUG	Vindesine	Cytostatic drug
DRUG	Etoposide	Cytostatic drug
DRUG	Prednisolone	Antileukemic drug
DRUG	Adriamycin	Cytostatic drug
DRUG	Thioguanine	Cytostatic drug
DRUG	Teniposide	Cytostatic drug
PROCEDURE	CNS irradiation	Cytostatic drug
PROCEDURE	Mediastinal Irradiation	Irradiation
PROCEDURE	Stem cell transplantation (SCT)	Stem cell transplantation
DRUG	Idarubicin	Cytostatic drug
DRUG	Fludarabine	Cytostatic drug
DRUG	Cladribine	Cytostatic drug

Timeline

• Start date: 2003-04-01
• Primary completion: 2011-06-30
• Completion: 2013-06-30
• First posted: 2005-09-20
• Last updated: 2022-08-18

Locations

1 site across 1 country: Germany