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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00198991
Other study ID # GMALL01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT00198978 - German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Phase 4
Completed NCT00199095 - Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia Phase 4
Completed NCT00199108 - Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt Phase 2/Phase 3
Completed NCT00199004 - Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab Phase 4
Completed NCT00199069 - German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93) Phase 4