Adults B-ALL and Burkitt´s Lymphoma
Conditions
Interventions
Trade Name: MabThera
Product Name: MabThera (Rituximab)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
PETHEMA Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To define prognostic factors To evaluate the significance of minimal residual disease (MRD) ;Primary end point(s): CR rate, DFS and OS | — |
Countries
Spain
Outcome results
None listed