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

Goethe University

Status and phase: Completed; Phase 4

Conditions: Adult Acute Lymphocytic Leukemia

Treatments: Drug: Asparaginase; Drug: Adriamycin; Drug: G-CSF; Drug: Prednisolone; Drug: Daunorubicin; Drug: Dexamethasone; Drug: Etoposide; Drug: Vindesine; Drug: Idarubicin; Drug: Methotrexate; Procedure: Mediastinal Irradiation; Drug: Cytarabine; Drug: Vincristine; Drug: Fludarabine; Drug: Teniposide; Drug: Cyclophosphamide; Procedure: Stem cell transplantation (SCT); Procedure: CNS irradiation; Drug: Mercaptopurine; Drug: Thioguanine; Drug: Cladribine

Study type: Interventional

Funder types: Other

Identifiers

NCT00198991

GMALL01

Details and patient eligibility

About

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.

Enrollment: 1,883 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,883 participants in 1 patient group

All patients

Experimental group

Description:

All patients are treated upfront according to one arm

Treatment:

Drug: Prednisolone

Drug: Daunorubicin

Drug: Vincristine

Procedure: Stem cell transplantation (SCT)

Drug: Thioguanine

Drug: Cladribine

Drug: Idarubicin

Drug: Adriamycin

Drug: G-CSF

Drug: Fludarabine

Drug: Teniposide

Drug: Cytarabine

Drug: Dexamethasone

Drug: Cyclophosphamide

Procedure: CNS irradiation

Drug: Vindesine

Drug: Mercaptopurine

Drug: Etoposide

Drug: Methotrexate

Procedure: Mediastinal Irradiation

Drug: Asparaginase