German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

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. A MRD based risk stratification and treatment decision is developed.

Official Title
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Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)

Conditions
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Adult Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Dexamethasone / Prednisolone
* Drug: Cyclophosphamide
* Drug: Methotrexate
* Drug: Vincristine / Vindesine
* Drug: Daunorubicin
* Drug: Asparaginase
* Drug: G-CSF
* Drug: Cytarabine
* Drug: 6-Mercaptopurine
* Drug: VP16
* Drug: Adriamycin
* Drug: Thioguanine
* Drug: VM26
* Drug: Idarubicin
* Drug: Fludarabine
* Drug: Ifosfamide
* Procedure: CNS irradiation
* Procedure: Mediastinal irradiation (if residual tumor)
* Procedure: stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T) Age 15-65 yrs (*55-65 years if biologically younger according to general condition) Exclusion Criteria: Severe comorbidity Cytostatic pre-treatment Pregnancy Missing written informed consent

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexamethasone / Prednisolone|nan|
|Drug: Cyclophosphamide|nan|
|Drug: Methotrexate|nan|
|Drug: Vincristine / Vindesine|nan|
|Drug: Daunorubicin|nan|
|Drug: Asparaginase|nan|
|Drug: G-CSF|nan|
|Drug: Cytarabine|nan|
|Drug: 6-Mercaptopurine|nan|
|Drug: VP16|nan|
|Drug: Adriamycin|nan|
|Drug: Thioguanine|nan|
|Drug: VM26|nan|
|Drug: Idarubicin|nan|
|Drug: Fludarabine|nan|
|Drug: Ifosfamide|nan|
|Procedure: CNS irradiation|nan|
|Procedure: Mediastinal irradiation (if residual tumor)|nan|
|Procedure: stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate,Remission duration,Disease free survival,Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL, Treatment, De Novo, Adult