A clinical trial to compare safety and efficacy of two formulations of Rituximab, both being administered in combination with CHOP chemotherapy regimen, in patients with Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Health Condition 1: null- Diffuse large B-cell lymphoma (DLBCL)
- Registration Number
- CTRI/2014/09/004959
- Lead Sponsor
- MABXIENCE SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 250
1.Patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/L. Any other procedure for measurable disease in particular cases, may be allowed upon Sponsor approval.
2.Newly diagnosed patients with a confirmed pathologic diagnosis of large B cell-non-Hodgkinâ??s lymphoma (DLBCL) with untreated CD20+. Defined by the local Haematopathologist at the local laboratory according to WHO criteria.
3.Stage II-III or IV or stage I with bulk defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.
4.Age-adjusted International Prognostic Index (IPI) score 0 or 1.
5.Age >=18 to <=65 years of age.
6.Performance status (Eastern Cooperative Oncology Group [ECOG]) of <=2.
7.Written informed consent obtained before starting any study specific procedure.
8.Females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intramuscular contraceptive).
1. Life expectancy of less than three months.
2. Any other lymphoma other than CD20+ DLBCL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate (RR): <br/ ><br>Tumour responses will be assessed after 6 cycles of chemotherapy or <br/ ><br>at the end of treatment and classified as Complete Response (CR), <br/ ><br>Partial Response (PR), Stable Disease (SD) or Progressive Disease <br/ ><br>(PD) according to the International Working Group criteria.Timepoint: Response Rate (RR): <br/ ><br>Tumour responses will be assessed after 6 cycles of chemotherapy or <br/ ><br>at the end of treatment and classified as Complete Response (CR), <br/ ><br>Partial Response (PR), Stable Disease (SD) or Progressive Disease <br/ ><br>(PD) according to the International Working Group criteria.
- Secondary Outcome Measures
Name Time Method Event Free Survival: Time to progressive disease under therapy, the events for which being: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, death from any cause, <br/ ><br>whichever comes first. <br/ ><br>Safety : AEs will be collected during the study and up to 30 days after the end of study treatment (graded according to the NCICTC <br/ ><br>criteria [v 4.0]).Timepoint: At the End of study.