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

NCT ID: NCT00797810

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

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.

Conditions

Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapy

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Interventions

Rituximab

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Dipartiemento di Ematoogia "seragnoli"- Policlinico Sant'Orsola di Bologna

Principal Investigators

Giovanni Martinelli, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Haematology "L.e A. Seragnoli" Bologne-Italy

Locations

Institute of Haematology "L. e A. Seragnoli"

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Martinelli, MD

Role: CONTACT

gmartino@alma.unibo.it

0516363829

Facility Contacts

Giovanni Martinelli, MD

Role: primary

Other Identifiers

HEMOS ALL1105

Identifier Type: -

Identifier Source: org_study_id