Chronic Lymphocytic Leukaemia MedDRA version: 20.0 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MabThera (rituximab)
Product Name: MabThera (Rituximab)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Concentr
Sponsors
Cancer Trials Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients 1 year •No concurrent malignancy except for non-invasive cervical cancer and localised non-melanomatous skin cancer •HIV negative •Not pregnant or lactating and willing to follow appropriate contraceptive advice Are the trial subjects under 18? no 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 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 10.2.2 Exclusion Criteria •Deletion of 17p •Any previous treatment for CLL except previous combination chemotherapy or treatment with Rituximab •History of anaphylaxis to mouse derived humanised monoclonal antibody •Creatinine clearance of <50mls/min •Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study •Lactation / Pregnancy •Active secondary malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Due to the experimental nature of the treatment and the fact that patients need to meet a number of different efficacy and safety milestones, analyses will be conducted throughout the study, but without any formal statistical testing. Toxicity will be reviewed every 6 months and efficacy will be reviewed annually, from 6 months post the last patient registered on the trial. Safety signals will be monitored on an ongoing basis. After the study has been fully closed, the data cleaned, and the database closed out, a complete statistical analysis report will be produced. This will be according to the Statistical Analysis Plan.;Main Objective: •Complete remission rate by NCI Criteria (Appendix 3) and using MRD analysis. ;Secondary Objective: •Time to Treatment Failure (TTF) in MRD positive versus negative patients. •Overall survival (OS) at 5 years. •Predictive value of immunophenotype, hypermutation analysis and FISH in determining TTF and OS. •Determine the safety profile of modified FCR. ;Primary end point(s): Complete remission rate achieved, using NCI Criteria and Minimal Residual Disease (MRD) analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: • Time to Treatment Failure (TTF) in MRD positive versus negative patients • Overall survival (OS) • Predictive value of immunophenotype, FISH and hypermutation analysis in determining TTF and OS Safety Endpoints: • Determine acute and chronic toxicity (NCI criteria);Timepoint(s) of evaluation of this end point: Due to the experimental nature of the treatment and the fact that patients need to meet a number of different efficacy and safety milestones, analyses will be conducted throughout the study, but without any formal statistical testing. Toxicity will be reviewed every 6 months and efficacy will be reviewed annually, from 6 months post the last patient registered on the trial. Safety signals will be monitored on an ongoing basis. After the study has been fully closed, the data cleaned, and the database closed out, a complete statistical analysis report will be produced. This will be according to the Statistical Analysis Plan. | — |
Countries
Ireland
Contacts
Public ContactHead of Clinical Operations
Cancer Trials Ireland
Outcome results
None listed