Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

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 in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

Official Title
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German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)

Conditions
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Adult Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Dexamethasone / Prednisolone
* Drug: Vincristine
* Drug: Daunorubicin
* Drug: Asparaginase
* Drug: Methotrexate
* Drug: Cytarabine
* Drug: Mercaptopurine
* Drug: G-CSF
* Drug: Vindesine
* Drug: VP16
* Drug: Adriamycin
* Drug: Thioguanine
* Drug: VM26
* Drug: Rituximab
* Procedure: CNS irradiation
* Procedure: Mediastinal irradiation (if residual TU)
* Procedure: Stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: B-precursor ALL (common / pre B-ALL) Standard risk CD20 expression >20% Ph/BCR-ABL negative Age 15-65 years (55-65 if biologically younger) Written informed consent Exclusion Criteria: Severe complications due to leukemia or secondary illnesses Late relapse of childhood ALL Cytostatic pretreatment Pregnancy Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent Known severe allergy to foreign proteins

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclophosphamide|nan|
|Drug: Dexamethasone / Prednisolone|nan|
|Drug: Vincristine|nan|
|Drug: Daunorubicin|nan|
|Drug: Asparaginase|nan|
|Drug: Methotrexate|nan|
|Drug: Cytarabine|nan|
|Drug: Mercaptopurine|nan|
|Drug: G-CSF|nan|
|Drug: Vindesine|nan|
|Drug: VP16|nan|
|Drug: Adriamycin|nan|
|Drug: Thioguanine|nan|
|Drug: VM26|nan|
|Drug: Rituximab|nan|
|Procedure: CNS irradiation|nan|
|Procedure: Mediastinal irradiation (if residual TU)|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 (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose and time compliance, Toxicity according to WHO, Death in induction and CR, 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, Minimal residual disease, Rituximab, Adult