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

Phase 4

Completed

• Conditions: Adult Acute Lymphocytic Leukemia
• Interventions: Drug: 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; Procedure: CNS irradiation; Procedure: Mediastinal Irradiation; Procedure: Stem cell transplantation (SCT); Drug: Idarubicin; Drug: Fludarabine; Drug: Cladribine

• Registration Number: NCT00198991
• Lead Sponsor: Goethe University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2011-06-30
• Study Completion: 2013-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1883

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Cladribine	All patients are treated upfront according to one arm
All patients	Stem cell transplantation (SCT)	All patients are treated upfront according to one arm
All patients	CNS irradiation	All patients are treated upfront according to one arm
All patients	Mediastinal Irradiation	All patients are treated upfront according to one arm
All patients	Vindesine	All patients are treated upfront according to one arm
All patients	Cyclophosphamide	All patients are treated upfront according to one arm
All patients	Dexamethasone	All patients are treated upfront according to one arm
All patients	Vincristine	All patients are treated upfront according to one arm
All patients	Thioguanine	All patients are treated upfront according to one arm
All patients	Daunorubicin	All patients are treated upfront according to one arm
All patients	Asparaginase	All patients are treated upfront according to one arm
All patients	Methotrexate	All patients are treated upfront according to one arm
All patients	Mercaptopurine	All patients are treated upfront according to one arm
All patients	Cytarabine	All patients are treated upfront according to one arm
All patients	G-CSF	All patients are treated upfront according to one arm
All patients	Etoposide	All patients are treated upfront according to one arm
All patients	Prednisolone	All patients are treated upfront according to one arm
All patients	Adriamycin	All patients are treated upfront according to one arm
All patients	Teniposide	All patients are treated upfront according to one arm
All patients	Idarubicin	All patients are treated upfront according to one arm
All patients	Fludarabine	All patients are treated upfront according to one arm

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 10 years	Rate and probability of patients remaining alive
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

Secondary Outcome Measures

Name	Time	Method
Realisation of Stem cell transplantation (SCT)	up to 10 years	Rate of patients receiving an SCT
Toxicity according to WHO/CTCAE	after each cycle up to 2.5 years	Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)
Response assessment based on MRD	up to 5 years	Rate of MRD response after specific cycles

Trial Locations

Locations (1)

University of Frankfurt, Medical Dept. II; 🇩🇪 Frankfurt, Germany