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Trial registered on ANZCTR


Registration number
ACTRN12610000060044
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
19/01/2010
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Date results information initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The research project is trying to find out if we can improve the results of best available chemotherapy for Chronic Lymphocytic Leukaemia (CLL) by the addition of a new drug called lenalidomide.
Scientific title
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
Secondary ID [1] 1287 0
CLL6
Universal Trial Number (UTN)
Trial acronym
RESIDUUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukaemia (CLL) 256539 0
Condition category
Condition code
Cancer 256712 256712 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 2.5mg increments every 2 cycles. At day 28 patient will undergo blood tests to ensure safe to continue with treatment. A new cycle will commence at the appropriate dose. This will occur for 24 months (2years).
Intervention code [1] 255816 0
Treatment: Drugs
Comparator / control treatment
the observation patients compared to the Lenalidomide treated patients
Control group
Active

Outcomes
Primary outcome [1] 257598 0
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 [1] 257598 0
from randomisation until either disease progresses or death occurs.
Secondary outcome [1] 262865 0
Conversion to Minimal Residual Disease (MRD) negativity for randomized patients. Measured by flow cytometry of Bone Marrow sample.
Timepoint [1] 262865 0
from commencement of Lenalidomide. Lenalidomide treatment is for 2years.
Secondary outcome [2] 262866 0
Time to requirement for next therapy after Lenalidomide.
Timepoint [2] 262866 0
from when Lenalidomide is finished to time until next therapy is prescribed for the patient.
Secondary outcome [3] 262867 0
Percentage of patients with improvement in disease response. Results from routine tests such as bone marrow biospy and blood test will be used.
Timepoint [3] 262867 0
Patients will be monitored for evidence of disease progresssion using clinical, radiological and flow cytometry according to standardised international criteria.At regular timepoins during and after treatment. Timepoints may vary due to patient tolerance of Lenalidomide.
Secondary outcome [4] 262868 0
Overall survival, measured by clinician at follow up.
Timepoint [4] 262868 0
from time of registration to final followup. (for three years from time of last randomisation)
Secondary outcome [5] 262869 0
Tolerability of Lenalidomide consolidation.Measured by assessing patient ability to go on with next planned cycles - involves blood tests to ensure blood counts have recovered satisfactorily so as next cycle can be commenced.
Timepoint [5] 262869 0
monthly assessment of patient tolerability for the 2years of Lenalidomide maintenance therapy.

Eligibility
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 Axial Tomography Scan (CT) hepatomegaly or splenomegaly, positive bone marrow histology (including the persistence of three or
more lymphoid nodules, regardless of immunohistochemical features), or detectable minimal residual disease (MRD) in blood or
marrow obtained from flow cytometry result performed at Westmead Hospital Flow Cytometry Unit. Adequate haematological recovery following chemotherapy (haemoglobin (Hb) > 110g/L, neutrophils > 1.5 x 10^9/L,
platelets >100 x 10^9/L). Alkaline phosphatase and transaminases lessthan or equal to 2 x Upper Limit of Normal (ULN). Creatinine clearance greaterthan or equal to 30 ml/min at Screening (calculated by Cockcroft-Gault formula. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation Male patients must use contraception during lenalidomide treatment and for 1 week after Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Life expectancy greater than 6 months. Patient’s written informed consent. Subjects must agree not to donate blood, semen or sperm while on study treatment and for 1 week after treatment discontinuation. Subjects must agree not to share their medication and to return unused supplies.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 nervous system disease or cerebral dysfunction. Transformation to aggressive B-cell malignancy, e.g. diffuse large cell lymphoma, Richter’s syndrome or prolymphocytic leukaemia. Active bacterial, viral or fungal infection at Screening. Human Immuno-deficiency Virus (HIV) infection. Positivity for Hepatitis B Virus (HBV) surface antigen or HBV surface antibody unless due to vaccination. Any coexisting medical or psychological condition that would preclude participation in the required study procedures. Pregnancy and lactation. Vaccination with a ‘live’ vaccine at any time during the study Trial participant not accessible for duration of trial including follow up.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomised in a 1:1 ratio, as noted above.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 2404 0
France
State/province [1] 2404 0

Funding & Sponsors
Funding source category [1] 256308 0
Commercial sector/Industry
Name [1] 256308 0
Celgene
Address [1] 256308 0
Celgene Pty Ltd
G2/64 Talavera Road
North Ryde, NSW 2113
Country [1] 256308 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group (ALLG)
Address
35 Elizabeth Street, Richmond 3121 Victoria
Country
Australia
Secondary sponsor category [1] 251627 0
None
Name [1] 251627 0
Address [1] 251627 0
Country [1] 251627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258391 0
St Vincent's Hopital HREC
Ethics committee address [1] 258391 0
PO Box 2900 Fitzroy Victoria, 3065
Ethics committee country [1] 258391 0
Australia
Date submitted for ethics approval [1] 258391 0
01/12/2010
Approval date [1] 258391 0
20/12/2010
Ethics approval number [1] 258391 0
HREC/10/SVHM/67

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30700 0
Prof David Gottlieb
Address 30700 0
Westmead Hospital Haematology Department Westmead, corner Hawkesbury Road and Darcy Road, Westmead New South Wales 2145
Country 30700 0
Australia
Phone 30700 0
+61, 02, 98456033
Fax 30700 0
Email 30700 0
david.gottlieb@sydney.edu.au
Contact person for public queries
Name 13947 0
Ms Delaine Smith
Address 13947 0
The Australasian Leukaemia and Lymphoma Group (ALLG)
Ground floor, 35 Elizabeth Street, Richmond 3121 Victoria
Country 13947 0
Australia
Phone 13947 0
61 383739701
Fax 13947 0
61 394298277
Email 13947 0
delaine.smith@allg.org.au
Contact person for scientific queries
Name 4875 0
Prof Professor David Gottlieb
Address 4875 0
Westmead Hospital
Haematology Department
Westmead
New South Wales
Country 4875 0
Australia
Phone 4875 0
610298456033
Fax 4875 0
Email 4875 0
not available

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be publicly available as it is the aggregate data that is under investigation
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary