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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adult Acute Lymphocytic Leukemia

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>All patients are treated upfront according to one arm | Drug: Cyclophosphamide<br>* Cytostatic drug<br>Drug: Dexamethasone<br>* Antileukemic drug<br>Drug: Vincristine<br>* Cytostatic drug<br>Drug: Daunorubicin<br>* Cytostatic drug<br>Drug: Asparaginase<br>* Cytostatic drug<br>* Other names: Pegylated Asparaginase;Drug: Methotrexate<br>* Cytostatic drug<br>Drug: Cytarabine<br>* Cytostatic drug<br>Drug: Mercaptopurine<br>* Cytostatic drug<br>Drug: G-CSF<br>* Growth factor<br>Drug: Vindesine<br>* Cytostatic drug<br>Drug: Etoposide<br>* Cytostatic drug<br>* Other names: Etoposide Phosphate;Drug: Prednisolone<br>* Antileukemic drug<br>Drug: Adriamycin<br>* Cytostatic drug<br>Drug: Thioguanine<br>* Cytostatic drug<br>Drug: Teniposide<br>* Cytostatic drug<br>Procedure: CNS irradiation<br>* Cytostatic drug<br>Procedure: Mediastinal Irradiation<br>* Irradiation<br>Procedure: Stem cell transplantation (SCT)<br>* Stem cell transplantation<br>Drug: Idarubicin<br>* Cytostatic drug<br>Drug: Fludarabine<br>* Cytostatic drug<br>Drug: Cladribine<br>* Cytostatic drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate | Rate of patients with complete remission | day 46 | 
| Remission duration | Rate and probability of patients with ongoing remission after prior achievement of remission | up to 10 years | 
| 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 | 
| Overall survival | Rate and probability of patients remaining alive | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Realisation of Stem cell transplantation (SCT) | Rate of patients receiving an SCT | up to 10 years | 
| 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 | 
| Response assessment based on MRD | Rate of MRD response after specific cycles | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL, Treatment, de novo, Minimal residual disease, Adult