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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00797810
• Other study ID #: HEMOS ALL1105
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2008
• Last updated: September 14, 2009
• Start date: December 2006

Study information

• Verified date: September 2009
• Source: University of Bologna
• Contact: Giovanni Martinelli, MD
• Phone: 0516363829
• Email: gmartino[@]alma.unibo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
Italy	Institute of Haematology "L. e A. Seragnoli"	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test of the tolerability and efficacy of new therapy elements to improve remission
Primary	Rates, overall survival and remission duration
Primary	Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
Primary	Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
Primary	Prophylactic administration of G-CSF after every cycle of chemotherapy
Primary	Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor
Secondary	Test of the age-adapted therapy stratification according to biological age
Secondary	(18< age <55)
Secondary	Definition of prognostic factors
Secondary	Setting up of a central reference pathology panel