Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Trial Sites
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Phase | Type | Status | Age | Sponsor | Protocol IDs |
---|---|---|---|---|---|
Phase IV | Treatment | Active | 18 and over | Other | HEMOS ALL1105 NCT00797810 |
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.
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
Trial Lead Organizations/Sponsors
University of Bologna Medical School
Giovanni Martinelli | Principal Investigator |
Giovanni Martinelli, MD | Ph: 0516363829 | |
Email: gmartino@alma.unibo.it |
Trial Sites
Italy | |||
Bologna | |||
Seragnoli Institute of Hematology and Medical Oncology | |||
Giovanni Martinelli, MD | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00797810
Information obtained from ClinicalTrials.gov on December 14, 2011
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
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