Diffuse large B-cell lymphoma and chronic lymphocytic leukaemia Cancer Diffuse large B-cell lymphoma, chronic lymphocytic leukaemia of B-cell type
Conditions
Interventions
The study will enroll patients who recently started treatment with Reditux™ or the RMP for previously untreated DLBCL or CLL in routine clinical practice. All treatment decisions (Reditux, Ristova & M
Sponsors
Dr. Reddy’s Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18; 2. Willing and able to provide written informed consent. 3. Previously untreated DLBCL or CLL. 4. Was recently administered first cycle of Reditux™ or the RMP (before the administration of 2nd cycle), at any dose, either in monotherapy or part of a combined treatment regimen, in routine clinical practice. 5. Participating in other non-interventional studies or registries as long as their participation does not interfere with this protocol or likely to affect the patient’s ability to comply with this protocol can be included in this study.
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in an investigational study in which treatment, procedures, patient assessments are dictated by a protocol; 2. Starting treatment with a rituximab product other than Reditux™, MabThera®, or Ristova®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Event-free survival at 2 years. 2. Objective response rate (complete remission and partial remission) is determined using “CT/PET/MRI/Bone Marrow/Physical Examination/CBC reports” at “2 years”. 3. The incidence of safety events is determined using “Adverse Events reported” at “2 years”. 4. Quality of Life will be measured using the EQ-5D at 2 years. | — |
Countries
India
Contacts
Public ContactRakesh Naranbhai Dadhania
Outcome results
None listed