Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00774345
Ethics application status
Date submitted
16/10/2008
Date registered
17/10/2008
Date last updated
2/12/2021

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

Placebo comparator: 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 (OS)
Timepoint [1] 0 0
Up to approximately 11 years
Secondary outcome [1] 0 0
Progression Free Survival 2 (PFS2)
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [2] 0 0
From first dose to 30 days post last dose (up to 9 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/10/2020
Sample size
Target
Accrual to date
Final
317
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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Austria
State/province [24] 0 0
Innsbruck
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Brugge
Country [28] 0 0
Belgium
State/province [28] 0 0
Brussels
Country [29] 0 0
Belgium
State/province [29] 0 0
Bruxelles
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Haine-Saint Paul
Country [32] 0 0
Belgium
State/province [32] 0 0
Kortrijk
Country [33] 0 0
Belgium
State/province [33] 0 0
Leuven
Country [34] 0 0
Belgium
State/province [34] 0 0
Yvoir
Country [35] 0 0
Canada
State/province [35] 0 0
New Brunswick
Country [36] 0 0
Canada
State/province [36] 0 0
Newfoundland and Labrador
Country [37] 0 0
Canada
State/province [37] 0 0
Nova Scotia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Colombia
State/province [40] 0 0
Monteria
Country [41] 0 0
Czechia
State/province [41] 0 0
Brno
Country [42] 0 0
Czechia
State/province [42] 0 0
Hradec Kralove
Country [43] 0 0
Czechia
State/province [43] 0 0
Novy Jicin
Country [44] 0 0
Czechia
State/province [44] 0 0
Plzen
Country [45] 0 0
Czechia
State/province [45] 0 0
Prague
Country [46] 0 0
Denmark
State/province [46] 0 0
Copenhagen
Country [47] 0 0
Denmark
State/province [47] 0 0
Odense
Country [48] 0 0
Denmark
State/province [48] 0 0
Vejle
Country [49] 0 0
France
State/province [49] 0 0
Bobigny Cedex
Country [50] 0 0
France
State/province [50] 0 0
Bordeaux
Country [51] 0 0
France
State/province [51] 0 0
Clermont Ferrand
Country [52] 0 0
France
State/province [52] 0 0
Grenoble Cedex 09
Country [53] 0 0
France
State/province [53] 0 0
Lyon
Country [54] 0 0
France
State/province [54] 0 0
Nantes cedex 01
Country [55] 0 0
France
State/province [55] 0 0
Nice
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Poitiers
Country [58] 0 0
France
State/province [58] 0 0
Reims cedex
Country [59] 0 0
France
State/province [59] 0 0
Rouen
Country [60] 0 0
France
State/province [60] 0 0
Tours Cedex
Country [61] 0 0
Germany
State/province [61] 0 0
Berlin
Country [62] 0 0
Germany
State/province [62] 0 0
Essen
Country [63] 0 0
Germany
State/province [63] 0 0
Frankfurt (Oder)
Country [64] 0 0
Germany
State/province [64] 0 0
Freiburg
Country [65] 0 0
Germany
State/province [65] 0 0
Hannover
Country [66] 0 0
Germany
State/province [66] 0 0
Koblenz
Country [67] 0 0
Germany
State/province [67] 0 0
Köln
Country [68] 0 0
Germany
State/province [68] 0 0
Leipzig
Country [69] 0 0
Germany
State/province [69] 0 0
Mannheim
Country [70] 0 0
Germany
State/province [70] 0 0
München
Country [71] 0 0
Germany
State/province [71] 0 0
Münster
Country [72] 0 0
Germany
State/province [72] 0 0
Ulm
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Gyor
Country [76] 0 0
Hungary
State/province [76] 0 0
Kaposvar
Country [77] 0 0
Hungary
State/province [77] 0 0
Pecs
Country [78] 0 0
Hungary
State/province [78] 0 0
Szeged
Country [79] 0 0
Hungary
State/province [79] 0 0
Tatabanya
Country [80] 0 0
Ireland
State/province [80] 0 0
Dublin
Country [81] 0 0
Ireland
State/province [81] 0 0
Limerick
Country [82] 0 0
Israel
State/province [82] 0 0
Afula
Country [83] 0 0
Israel
State/province [83] 0 0
Ashkelon
Country [84] 0 0
Israel
State/province [84] 0 0
Beer Sheva
Country [85] 0 0
Israel
State/province [85] 0 0
Haifa
Country [86] 0 0
Israel
State/province [86] 0 0
Jerusalem
Country [87] 0 0
Israel
State/province [87] 0 0
Kfar-Saba
Country [88] 0 0
Israel
State/province [88] 0 0
Naharia
Country [89] 0 0
Israel
State/province [89] 0 0
Petach Tikva
Country [90] 0 0
Israel
State/province [90] 0 0
Rehovot
Country [91] 0 0
Israel
State/province [91] 0 0
Tel Aviv
Country [92] 0 0
Israel
State/province [92] 0 0
Tel Hashomer
Country [93] 0 0
Italy
State/province [93] 0 0
Bari
Country [94] 0 0
Italy
State/province [94] 0 0
Brescia
Country [95] 0 0
Italy
State/province [95] 0 0
Catania
Country [96] 0 0
Italy
State/province [96] 0 0
Catanzaro
Country [97] 0 0
Italy
State/province [97] 0 0
Cosenza
Country [98] 0 0
Italy
State/province [98] 0 0
Ferrara
Country [99] 0 0
Italy
State/province [99] 0 0
Florence
Country [100] 0 0
Italy
State/province [100] 0 0
Foggia
Country [101] 0 0
Italy
State/province [101] 0 0
Genova
Country [102] 0 0
Italy
State/province [102] 0 0
Milano
Country [103] 0 0
Italy
State/province [103] 0 0
Milan
Country [104] 0 0
Italy
State/province [104] 0 0
Modena
Country [105] 0 0
Italy
State/province [105] 0 0
Naples
Country [106] 0 0
Italy
State/province [106] 0 0
Novara
Country [107] 0 0
Italy
State/province [107] 0 0
Padova
Country [108] 0 0
Italy
State/province [108] 0 0
Potenza
Country [109] 0 0
Italy
State/province [109] 0 0
Rome
Country [110] 0 0
Italy
State/province [110] 0 0
Siena
Country [111] 0 0
Italy
State/province [111] 0 0
Torino
Country [112] 0 0
Italy
State/province [112] 0 0
Torrette Di Ancona
Country [113] 0 0
Italy
State/province [113] 0 0
Vicenza
Country [114] 0 0
Mexico
State/province [114] 0 0
Aguascalientes
Country [115] 0 0
Netherlands
State/province [115] 0 0
Amsterdam
Country [116] 0 0
New Zealand
State/province [116] 0 0
Christchurch
Country [117] 0 0
New Zealand
State/province [117] 0 0
Manukau
Country [118] 0 0
New Zealand
State/province [118] 0 0
Takapuna
Country [119] 0 0
Poland
State/province [119] 0 0
Gdansk
Country [120] 0 0
Poland
State/province [120] 0 0
Kraków
Country [121] 0 0
Poland
State/province [121] 0 0
Lodz
Country [122] 0 0
Poland
State/province [122] 0 0
Torun
Country [123] 0 0
Poland
State/province [123] 0 0
Warszawa
Country [124] 0 0
Poland
State/province [124] 0 0
Wroclaw
Country [125] 0 0
Portugal
State/province [125] 0 0
Coimbra
Country [126] 0 0
Portugal
State/province [126] 0 0
Lisbon
Country [127] 0 0
Portugal
State/province [127] 0 0
Porto
Country [128] 0 0
Romania
State/province [128] 0 0
Bucharest
Country [129] 0 0
Romania
State/province [129] 0 0
Iasi
Country [130] 0 0
Romania
State/province [130] 0 0
Sibiu
Country [131] 0 0
Romania
State/province [131] 0 0
Timisoara
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Arkhangelsk
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Barnaul
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Ekaterinburg
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Kazan
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Krasnoyarsk
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Moscow
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Nizhniy Novgorod
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Novosibirsk
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Obninsk
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Saratov
Country [142] 0 0
Russian Federation
State/province [142] 0 0
St. Petersburg
Country [143] 0 0
Russian Federation
State/province [143] 0 0
St.Petersburg
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Volgograd
Country [145] 0 0
South Africa
State/province [145] 0 0
Cape Town
Country [146] 0 0
South Africa
State/province [146] 0 0
Parktown
Country [147] 0 0
South Africa
State/province [147] 0 0
Pretoria
Country [148] 0 0
Spain
State/province [148] 0 0
Badalona
Country [149] 0 0
Spain
State/province [149] 0 0
Barcelona
Country [150] 0 0
Spain
State/province [150] 0 0
Madrid
Country [151] 0 0
Spain
State/province [151] 0 0
Majadahonda
Country [152] 0 0
Spain
State/province [152] 0 0
Malaga
Country [153] 0 0
Spain
State/province [153] 0 0
Murcia
Country [154] 0 0
Spain
State/province [154] 0 0
Salamanca
Country [155] 0 0
Spain
State/province [155] 0 0
San Sebastian
Country [156] 0 0
Spain
State/province [156] 0 0
Santander
Country [157] 0 0
Spain
State/province [157] 0 0
Valencia
Country [158] 0 0
Sweden
State/province [158] 0 0
Lund
Country [159] 0 0
Sweden
State/province [159] 0 0
Stockholm
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Bournemouth
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Cambridge
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Glasgow
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Headington
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Leeds
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Liverpool
Country [166] 0 0
United Kingdom
State/province [166] 0 0
London
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Manchester
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Sheffield
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Swansea
Country [170] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00774345