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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00774345




Registration number
NCT00774345
Ethics application status
Date submitted
16/10/2008
Date registered
17/10/2008
Date last updated
13/12/2019

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)
Secondary ID [1] 0 0
CC-5013-CLL-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Placebo

Experimental: 1 - Lenalidomide po qd on days 1-28 of a 28 day cycle

Placebo Comparator: 2 - Placebo capsules given orally on days 1-28 of a 28 day cycle


Treatment: Drugs: Lenalidomide
Lenalidomide capsules given orally on days 1-28 of a 28 day cycle

Treatment: Drugs: Placebo
Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival is defined as the time from randomization to death of any cause
Timepoint [1] 0 0
8 years
Primary outcome [2] 0 0
240 Events For Progression Free Survival - Progression free survival (PFS) is defined as the time from randomization to disease progression or death due to any cause during or after the treatment period, whichever comes first
Timepoint [2] 0 0
6 years
Secondary outcome [1] 0 0
The number, type, frequency and severity of adverse events (AEs) - An adverse event (AE) is any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria below), regardless of etiology. Any medical condition that was present prior to study treatment and that remains unchanged or improved should not be recorded as an AE. If there is a worsening of that medical condition, this should be considered an AE.
Timepoint [1] 0 0
Up to 8 years; All AEs will be recorded by the Investigator(s) from the time of signing of informed consent
Secondary outcome [2] 0 0
Tumor Response - Tumor response is defined as the patient's best response to treatment as defined by the iwCLL guidelines.
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Duration of Response - Duration of response is defined as the time from first evaluation of an improved response from the patient's baseline condition until progression of disease.
Timepoint [3] 0 0
6 years
Secondary outcome [4] 0 0
Health Related Quality of Life-Fact Leukemia Survey Version 4.0 - The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease.
Timepoint [4] 0 0
6 years
Secondary outcome [5] 0 0
Health Related Quality of Life EQ5-D - The standardized extended version of EQ-5D was designed for the collection of health state. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions
Timepoint [5] 0 0
6 years

Eligibility
Key inclusion criteria
1. Must understand and voluntarily sign an informed consent form.

2. Must be greater than or equal to 18 years at the time of signing the informed consent
form.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and
treatment of chronic lymphocytic leukemia [Hallek, 2008]).

5. Must have been treated with one of the following in first and/or second line:

- a purine analog-containing regimen

- a bendamustine-containing regimen

- an anti-CD20 antibody-containing regimen

- a chlorambucil-containing regimen

- an alemtuzumab-containing regimen (for those subjects with a 17p deletion)

6. Must have achieved a minimum response of partial response (PR, nPR, CRi, CR, and
MRD-negative CR) (IWCLL guidelines for the diagnosis and treatment of chronic
lymphocytic leukemia [Hallek, 2008]) following completion of second-line induction
therapy prior to randomization (documentation of response status must be available).
Second-line induction therapy must be documented to have been of sufficient duration.

7. Must have completed last cycle of second-line induction no less than 8 weeks (56 days)
and no greater than 20 weeks (140 days) prior to randomization.

8. Must have an ECOG performance status score of less than or equal to 2.

9. Females of childbearing potential (FCBP)† must:

- Have two negative medically supervised pregnancy tests prior to starting of study
therapy. She must agree to ongoing pregnancy testing during the course of the
study, and after end of study therapy. This applies even if the subject practices
complete and continued sexual abstinence.

- Either commit to continued abstinence from heterosexual contact (which must be
reviewed on a monthly basis) or agree to use, and be able to comply with,
effective contraception without interruption, 28 days prior to starting study
drug, during the study therapy (including dose interruptions), and for 28 days
after discontinuation of study therapy.

10. Male subjects must:

- Commit to continued abstinence from heterosexual contact or agree to use a condom
during sexual contact with a FCBP, even if they have had a vasectomy, throughout
study drug therapy, during any dose interruption and after cessation of study
therapy.

- Agree to not donate semen during study drug therapy and for a period after end of
study drug therapy.

11. All subjects must:

- Have an understanding that the study drug could have a potential teratogenic
risk.

- Agree to abstain from donating blood while taking study drug therapy and
following discontinuation of study drug therapy. • Agree not to share study
medication with another person.

- All subjects must be counseled about pregnancy precautions and risks of fetal
exposure.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from participating in the study.

2. Active infections requiring systemic antibiotics.

3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
treatment in spite of adequate anti-infective therapy

4. Autologous or allogeneic bone marrow transplant as second-line therapy.

5. Pregnant or lactating females.

6. Systemic treatment for B-cell CLL in the interval between completing the last cycle of
second-line induction therapy and randomization.

7. Participation in any clinical study or having taken any investigational therapy for a
disease other than CLL within 28 days prior to initiating maintenance therapy.

8. Known presence of alcohol and/or drug abuse.

9. Central nervous system involvement as documented by spinal fluid cytology or imaging.
Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of
leukemic meningitis must have a lumbar puncture procedure performed within two weeks
prior to randomization.

10. Prior history of malignancies, other than CLL, unless the subject has been free of the
disease for =5 years. Exceptions include the following:

- Basal cell carcinoma of the skin

- Squamous cell carcinoma of the skin

- Carcinoma in situ of the cervix

- Carcinoma in situ of the breast

- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)

11. History of renal failure requiring dialysis.

12. Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or
active Hepatitis C Virus (HCV) infection.

13. Prior therapy with lenalidomide.

14. Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be
enrolled upon correction of electrolyte abnormalities).

15. Any of the following laboratory abnormalities:

- Calculated (method of Cockroft-Gault) creatinine clearance <60 mL/min.

- Absolute neutrophil count (ANC) <1,000/µL (1.0 X 109/L)

- Platelet count <50,000/µL (50 X 109/L)

- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase
(SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT)
> 3.0 x upper limit of normal (ULN)

- Serum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)

16. Grade 4 rash due to prior thalidomide treatment

17. Uncontrolled hyperthyroidism or hypothyroidism

18. Venous thromboembolism within one year

19. Greater than or equal to Grade-2 neuropathy

20. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

21. Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)

22. Known allergy to allopurinol for subjects assessed with PR following their second-line
induction therapy.

23. Prisoners.

24. More than 2 prior lines of CLL therapy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Haematology and Oncology Clinics of Australasia - South Brisbane
Recruitment hospital [3] 0 0
IMVS - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [7] 0 0
Frankston Hospital - Farkston
Recruitment hospital [8] 0 0
St. Vincent Hospital - Fitzroy
Recruitment hospital [9] 0 0
Nepean Hospital - Kingswood, NSW
Recruitment hospital [10] 0 0
Clinical Trials Unit The St George Hospital - Kogarah
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 0 0
Royal North Shore HospitalDepartment of HematologyLevel 4 - St. Leonards
Recruitment hospital [13] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 SA - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
2050 - Camperdown
Recruitment postcode(s) [6] 0 0
3006 - East Melbourne
Recruitment postcode(s) [7] 0 0
3199 - Farkston
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
2751 - Kingswood, NSW
Recruitment postcode(s) [10] 0 0
2217 - Kogarah
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
2065 - St. Leonards
Recruitment postcode(s) [13] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Louisiana
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Massachusetts
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Nevada
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Iasi
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Romania
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Barnaul
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Moscow
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South Africa
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Pretoria
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United Kingdom
State/province [170] 0 0
West Bromwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective
as a maintenance therapy at improving further the quality of the response you achieved with
your last therapy and at prolonging the duration of your response. This study will compare
the effects (good and bad) of lenalidomide with the dummy drug.
Trial website
https://clinicaltrials.gov/show/NCT00774345
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Delarue, MD
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications