ClinicalTrials.Veeva

Menu

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

G

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems