An Australasian and French Phase III, Multicentre, Randomised Trial Comparing Lenalidomide Consolidation versus No Consolidation in Patients With Chronic Lymphocytic Leukaemia and Residual Disease Following Induction Chemotherapy (CLL6)
Australasian Leukaemia and Lymphoma Group (ALLG)Licence & Rights
This dataset is currently under embargo. The dataset is expected to be available on approximately 30-Jun-2027. Data requests are being accepted, with the proviso that data will only be shared following the primary publication and all other restrictions being met.
Dataset description
This dataset contains individual participant data (IPD) from the CLL6 study, a phase III randomised trial evaluating lenalidomide consolidation versus no consolidation in patients with chronic lymphocytic leukaemia (CLL) with residual disease following induction chemotherapy. The dataset includes patient-level demographic and clinical information such as age, sex, disease characteristics, prognostic markers, and baseline laboratory values. Treatment data include consolidation therapy allocation, dosing, and duration. Outcome data include response assessments, minimal residual disease status, progression-free survival, overall survival, and adverse events. The study population comprises approximately 192 adult patients with CLL and residual disease following induction therapy. Data are collected at predefined timepoints including baseline, post-induction, during consolidation (where applicable), and during scheduled follow-up for disease assessment and survival outcomes. Participants were recruited at sites in, Australia wide). The study commenced in 2011 and conducted the last patient last visit in 2018. This dataset is suitable for secondary analyses including evaluation of consolidation strategies, disease response, long-term outcomes, and optimisation of treatment approaches in CLL.Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12610000060044
Funding
Commercial sector/Industry, Celgene
Scientific enquiries
Prof Professor David Gottlieb
Brief Summary
to assess the effect of lenalidomide consolidation (vs observation with no further therapy) in previously untreated CLL patients with measurable disease after at least 4 cycles of FCR therapy.
Key Inclusion Criteria
B-cell Chronic Lymphocytic Leukaemia (CLL) confirmed according to World Health Organisation (WHO) Criteria. Age 18 years or older. Pre-Fludarabine chlorambucil (FC)/Fludarabine chlorambucil rituximab (FCR) chemotherapy blood sample desirable. Completed 4 to 6 cycles of FC or FCR, and within 3 – 6 months of last dose of chemotherapy. Achieved partial response or better following chemotherapy. Evidence of residual disease: at least one of clinical or CT lymphadenopathy >1.5cm, clinical or Computed .... Read more
Key Exclusion Criteria
Prior chemotherapy other than any of the following: a) chlorambucil given for CLL up to a cumulative dose 70mg/m2 b) FC and FCR induction chemotherapy. Active second malignancy currently requiring treatment (except for non-melanoma skin cancer or cervical cancer in-situ). Known hypersensitivity with anaphylactic reaction to lenalidomide. Class III or IV cardiac disease defined by the New York Heart Association (NYHA). Severe or debilitating pulmonary disease. Severe or debilitating central nervo .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 581
Min. age 18 Years
Max. age 0 No limit
Sex Both males and females
Condition category Chronic Lymphocytic Leukaemia (CLL)
Condition code Cancer
Intervention
Intervention code Treatment: Drugs
After initial chemotherapy (the standard routine chemotherapy given to patients with CLL) patients will be randomised to either follow-up or to new medication Lenalidomide. Patients randomised to followup will visit their clinician regularly and have blood tests for the same amount of time as those randomised to Lenalidomide. Those randomised to Lenalidomide will commence at 5mg (2.5 mg for those with renal impairment) and, if tolerated, escalate to a maximum of 10mg (5mg in renally impaired) in .... Read more
Comparison
Control group Active
the observation patients compared to the Lenalidomide treated patients
Outcomes
Outcome: Time to clinical disease progression, or death, from the date of randomisation. Patients will be monitored for evidence of disease progresssion using clinical, radiological and flow cytometry according to standardised international criteria.Timepoint: from randomisation until either disease progresses or death occurs.