Multicentre study of optimization of therapy in mature B-cell acute lymphoblastic leukemia and Burkitt's lymphoma in adults (over 15 years) - BURKIMAB
- Conditions
- Adults B-ALL and Burkitt´s Lymphoma
- Registration Number
- EUCTR2005-001067-64-ES
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1.B mature cell Acute Lymphoblastic Leukemia (B-ALL, L3-ALL)
2.Burkitt´s and Burkitt´s-like Lymphoma
3.Age = 15 years
Written informed consent of the patient
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Serious uncontrolled medical conditions related to ALL3 or Burkitt´s Lymphoma or secondary diseases
Previous chemotherapy treatment
Pregnancy or breast feading
Psychiatric disorders
Current participation in another clinical trial interfering with the investigational treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Analyze the efficacy (in terms of CR rate, DFS and OS) of a new therapeutic regimen including the adittion of anti-CD20 to a standard chemotherapy program. ;Secondary Objective: To analyze tolerance of this new therapeutic scheme<br>To define prognostic factors<br>To evaluate the significance of minimal residual disease (MRD)<br><br>;Primary end point(s): CR rate, DFS and OS
- Secondary Outcome Measures
Name Time Method