Chronic lymphocytic leukaemia (CLL) MedDRA version: 20.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Obinutuzumab
Product Name: Obinutuzumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Obinutuzumab
CAS Number: 949142-50-1
Trade Name: Fludarabine (oral)
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Will have participated in a CLL clinical trial that is selected for inclusion in the LTFU Study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: - has withdrawn from data collection from either their original trial or as part of LTFU Study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To follow-up all patients included in the LTFU Study until death in order to assess overall survival (OS);Secondary Objective: • Successfully import data from UK CLL clinical trials into the LTFU Study • The assessment of progression free survival (PFS) • The assessment of response to treatment across different trials and populations • The assessment of the long-term toxicity of CLL treatments including SARs/SUSARs, secondary cancers and other events of special interest. • The assessment of MRD negativity, MRD relapse, MRD growth rates and its the association of MRD with disease progression and survival. • The evaluation of the treatment pathways of patients with CLL who have participated in a clinical trial • The assessment of subgroups of patients across trials, in particular linked to analyses of their samples from the biobank ;Primary end point(s): • To follow-up all patients included in the LTFU Study until death in order to assess overall survival (OS) Endpoints will be listed and defined within each analysis proposal.;Timepoint(s) of evaluation of this end point: Annually. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Data imported from UK CLL clinical trial • Response to treatment • Progression-free survival • Long-term toxicity • Time to MRD relapse and MRD growth rate (for those who participated in ARCTIC, ADMIRE, COSMIC or GALACTIC) • Treatment for CLL ;Timepoint(s) of evaluation of this end point: Annually | — |
Countries
United Kingdom
Outcome results
None listed