NCT00199056

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (planned)
• 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. A MRD based risk stratification and treatment decision is developed.

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Dexamethasone / Prednisolone
DRUG	Cyclophosphamide
DRUG	Methotrexate
DRUG	Vincristine / Vindesine
DRUG	Daunorubicin
DRUG	Asparaginase
DRUG	G-CSF
DRUG	Cytarabine
DRUG	6-Mercaptopurine
DRUG	VP16
DRUG	Adriamycin
DRUG	Thioguanine
DRUG	VM26
DRUG	Idarubicin
DRUG	Fludarabine
DRUG	Ifosfamide
PROCEDURE	CNS irradiation
PROCEDURE	Mediastinal irradiation (if residual tumor)
PROCEDURE	stem cell transplantation

Timeline

• Start date: 1999-10-01
• Primary completion: 2003-11-01
• Completion: 2005-12-01
• First posted: 2005-09-20
• Last updated: 2023-03-20

Locations

1 site across 1 country: Germany