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

Adult Acute Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198991
• Other study ID #: GMALL01
• Status: Completed
• Phase: Phase 4
• Start date: April 2003
• Est. completion date: June 30, 2013

Study information

• Verified date: August 2022
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1883
• Est. completion date: June 30, 2013
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Cyclophosphamide
Cytostatic drug
• Dexamethasone
Antileukemic drug
• Vincristine
Cytostatic drug
• Daunorubicin
Cytostatic drug
• Asparaginase
Cytostatic drug
• Methotrexate
Cytostatic drug
• Cytarabine
Cytostatic drug
• Mercaptopurine
Cytostatic drug
• G-CSF
Growth factor
• Vindesine
Cytostatic drug
• Etoposide
Cytostatic drug
• Prednisolone
Antileukemic drug
• Adriamycin
Cytostatic drug
• Thioguanine
Cytostatic drug
• Teniposide
Cytostatic drug

Procedure:
• CNS irradiation
Cytostatic drug
• Mediastinal Irradiation
Irradiation
• Stem cell transplantation (SCT)
Stem cell transplantation

Drug:
• Idarubicin
Cytostatic drug
• Fludarabine
Cytostatic drug
• Cladribine
Cytostatic drug

Locations

Country	Name	City	State
Germany	University of Frankfurt, Medical Dept. II	Frankfurt

Sponsors (3)

Lead Sponsor	Collaborator
Goethe University	Deutsche Krebshilfe e.V., Bonn (Germany), German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate	Rate of patients with complete remission	day 46
Primary	Remission duration	Rate and probability of patients with ongoing remission after prior achievement of remission	up to 10 years
Primary	Disease free survival	Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy	up to 10 years
Primary	Overall survival	Rate and probability of patients remaining alive	up to 10 years
Secondary	Realisation of Stem cell transplantation (SCT)	Rate of patients receiving an SCT	up to 10 years
Secondary	Toxicity according to WHO/CTCAE	Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)	after each cycle up to 2.5 years
Secondary	Response assessment based on MRD	Rate of MRD response after specific cycles	up to 5 years

External Links

•   European Leukemia Trial Registry