Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

Study Overview
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Brief Summary
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All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3). Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement. In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.

Official Title
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Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

Conditions
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Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute lymphoblastic leukemia of the mature B-cell type (L3-ALL) High-grade non-Hodgkin's lymphoma of the following subtypes (WHO classification) Burkitt's lymphoma (including atypical Burkitt's lymphoma) Precursor B-lymphoblastic lymphoma Anaplastic large-cell lymphoma (Ki1+, B-, T- oder Null-cell-type) Mediastinal large B-cell-lymphoma (subtype of diffuse large B-cell lymphoma) Age = 18 years Patient's Informed Consent Exclusion Criteria: Serious complications caused by leukemia/ lymphoma or by a second illness: e.g. Severe, unmanageable complications such as sepsis, pneumonia with oxygen deficiency, Shock, hemorrhage at the time of diagnosis Renal insufficiency from leukemia/lymphoma-unrelated causes Severe cardiac or hepatic insufficiency Severe obstructive or restrictive lung disease that would compromise patient's treatment with intensified chemotherapy HIV infection Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy Known severe allergy to foreign proteins Cytostatic pretreatment for B-ALL/lymphoma (exceptions: short-term administration of steroids = 7 days, single administration of vincristine or cyclophosphamide, one cycle of CHOP, a single administration in an emergency of other cytostatic agents) for another malignant disease within the last 5 years Pregnancy/ nursing period Severe psychiatric illness or other circumstances giving ground to the assumption that a patient cannot give his consent to therapy or act co-operatively Absence of patient's informed consent Participation in another clinical study that would possibly interfere with study therapy

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: therapy<br> | Drug: Rituximab<br> <br> * Other names: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of the tolerability and efficacy of new therapy elements to improve remission |  |  | 
| Rates, overall survival and remission duration |  |  | 
| Administration of anti-CD20 (rituximab ®) together with combination chemotherapy |  |  | 
| Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C) |  |  | 
| Prophylactic administration of G-CSF after every cycle of chemotherapy |  |  | 
| Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of the age-adapted therapy stratification according to biological age |  |  | 
| (18< age <55) |  |  | 
| Definition of prognostic factors |  |  | 
| Setting up of a central reference pathology panel |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute lymphoblastic leukemia of the mature B-cell type, High-grade non-Hodgkin's lymphoma