Status:
UNKNOWN
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Lead Sponsor:
University of Bologna
Conditions:
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-pha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00797810
Start Date
December 1 2006
Last Update
September 15 2009
Active Locations (1)
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1
Institute of Haematology "L. e A. Seragnoli"
Bologna, Italy