Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

Study Overview
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Brief Summary
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The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Official Title
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Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)

Conditions
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Burkitt's Lymphoma, Burkitt's Leukemia, Mediastinal Neoplasms, Lymphoblastic Lymphoma, Large Cell Anaplastic Lymphoma

Intervention / Treatment
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* Drug: Adriamycin
* Drug: Cyclophosphamide
* Drug: Cytarabine
* Drug: Dexamethasone/Prednisolone
* Drug: VP16
* Drug: Ifosfamide
* Drug: Methotrexate
* Drug: G-CSF
* Drug: Rituximab
* Drug: Vincristine/Vindesine
* Procedure: Irradiation (in specific conditions)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma Age > 15 years Written informed consent Exclusion Criteria: Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected HIV infection Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy Known severe allergy to foreign proteins Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy. Pregnancy or nursing Participation in other studies that interfere with 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: Experimental<br>This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement | Drug: Adriamycin<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Cytarabine<br> <br> Drug: Dexamethasone/Prednisolone<br> <br> Drug: VP16<br> <br> Drug: Ifosfamide<br> <br> Drug: Methotrexate<br> <br> Drug: G-CSF<br> <br> Drug: Rituximab<br> <br> Drug: Vincristine/Vindesine<br> <br> Procedure: Irradiation (in specific conditions)<br> <br> |

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 |
| --- | --- | --- |
| Dose and time compliance |  |  | 
| Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) |  |  | 
| Death under therapy and in complete remission (CR) |  |  | 
| Localisations of relapse |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-grade NHL, De novo, Mature B-ALL, Burkitt'S NHL, Chemotherapy, Rituximab, Primary mediastinal diffuse large cell lymphoma, B-precursor lymphoblastic lymphoma