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

Sponsor

University of Bologna (Other)

Overall Status

Unknown status

CT.gov ID

NCT00797810

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma	Drug: Rituximab	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: therapy	Drug: Rituximab Other Names: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF

Arm

Intervention/Treatment

Experimental: therapy

Drug: Rituximab

Other Names:

Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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