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

NCT00198991 Phase 4 COMPLETED

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.

Details

Lead sponsor	Goethe University
Phase	Phase 4
Status	COMPLETED
Enrolment	1883
Start date	2003-04
Completion	2013-06-30

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

• Cyclophosphamide
• Dexamethasone
• Vincristine
• Daunorubicin
• Asparaginase
• Methotrexate
• Cytarabine
• Mercaptopurine
• G-CSF
• Vindesine

Primary outcomes

• Remission rate — day 46
  Rate of patients with complete remission
• Remission duration — up to 10 years
  Rate and probability of patients with ongoing remission after prior achievement of remission
• Disease free survival — up to 10 years
  Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy
• Overall survival — up to 10 years
  Rate and probability of patients remaining alive

Countries

Germany