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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Cyclophosphamide; Cytarabine; Dexamethasone; Ifosfamide; Prednisone; Rituximab; Vincristine

Criteria

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