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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00198991
Enrollment
1883
Registered
2005-09-20
Start date
2003-04-30
Completion date
2013-06-30
Last updated
2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL, Treatment, de novo, Minimal residual disease, Adult

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.

Interventions

DRUGCyclophosphamide

Cytostatic drug

DRUGDexamethasone

Antileukemic drug

DRUGVincristine

Cytostatic drug

DRUGDaunorubicin

Cytostatic drug

DRUGAsparaginase

Cytostatic drug

DRUGMethotrexate

Cytostatic drug

DRUGCytarabine

Cytostatic drug

DRUGMercaptopurine

Cytostatic drug

DRUGG-CSF

Growth factor

DRUGVindesine

Cytostatic drug

DRUGEtoposide

Cytostatic drug

DRUGPrednisolone

Antileukemic drug

DRUGAdriamycin

Cytostatic drug

DRUGThioguanine

Cytostatic drug

DRUGTeniposide

Cytostatic drug

PROCEDURECNS irradiation

Cytostatic drug

PROCEDUREMediastinal Irradiation

Irradiation

PROCEDUREStem cell transplantation (SCT)

Stem cell transplantation

DRUGIdarubicin

Cytostatic drug

DRUGFludarabine

Cytostatic drug

DRUGCladribine

Cytostatic drug

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Remission rateday 46Rate of patients with complete remission
Remission durationup to 10 yearsRate and probability of patients with ongoing remission after prior achievement of remission
Disease free survivalup to 10 yearsRate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy
Overall survivalup to 10 yearsRate and probability of patients remaining alive

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026