Observing the effectiveness and safety of Reditux and Reference Medicinal Product(s) to treat Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukaemia
- Conditions
- CancerDiffuse large B-cell lymphoma and chronic lymphocytic leukaemiaDiffuse large B-cell lymphoma, chronic lymphocytic leukaemia of B-cell type
- Registration Number
- ISRCTN13301166
- Lead Sponsor
- Dr. Reddy’s Laboratories
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37854680/ (added 19/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2000
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.
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®
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival at 2 years.
- Secondary Outcome Measures
Name Time Method 1. Event-free survival at 2 years.<br>2. Objective response rate (complete remission and partial remission) is determined using CT/PET/MRI/Bone Marrow/Physical Examination/CBC reports” at 2 years”.<br>3. The incidence of safety events is determined using Adverse Events reported” at 2 years”.<br>4. Quality of Life will be measured using the EQ-5D at 2 years.