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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second Line Therapy (THE CONTINUUM TRIAL)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
B-cell Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second Line Therapy (THE CONTINUUM TRIAL)


Inclusion Criteria:



1. Must sign an informed consent form.

2. Age ≥ 18 years

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.

5. Must have been treated with a purine analog- or bendamustine- containing regimen in
the first and/or second line induction therapy. Alemtuzumab-containing regimens in
place of purine analog- or bendamustine- containing regimens will also be allowed for
those patients with 17p deletion.

6. Must have achieved a minimum of partial response following completion of second-line
induction therapy.

7. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of
≤2.

8. Must agree to follow pregnancy precautions as required by the protocol.

9. Must agree to receive counseling related to teratogenic and other risks of
lenalidomide.

10. Must agree not to donate blood, eggs or sperm as defined by the protocol

Exclusion Criteria:

1. Any medical condition, that would prevent the subject from signing the informed
consent form.

2. Active infections requiring systemic antibiotics.

3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide

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

5. Pregnant or lactating females.

6. Participation in any clinical study or having taken any investigational therapy
within 28 days.

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

8. Central nervous system (CNS) involvement.

9. Prior history of malignancies, other than CLL, unless the subject has been free of
the disease for ≥3 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)

10. History of renal failure requiring dialysis.

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

12. Prior therapy with lenalidomide.

13. Presence of specific hematology and/or chemistry abnormalities

14. Severe rash due to prior thalidomide treatment

15. Uncontrolled hyperthyroidism or hypothyroidism

16. Venous thromboembolism within one year

17. ≥ Grade-2 neuropathy

18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

8 years

Safety Issue:

No

Principal Investigator

Jay Mei, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-CLL-002

NCT ID:

NCT00774345

Start Date:

January 2009

Completion Date:

August 2018

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103
Roswell Park Cancer InstituteBuffalo, New York  14263
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
New York Medical CollegeValhalla, New York  10595
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
Nevada Cancer Research FoundationLas Vegas, Nevada  89109
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
University of ColoradoDenver, Colorado  80217
Kaiser Permanente Medical GroupLos Angeles, California  90027
Abington Hematology Oncology AssociatesMeadowbrook, Pennsylvania  18974
Stanford Cancer CenterStanford, California  94305-5824
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain Cancer CentersThornton, Colorado  80260
Sharp Memorial HospitalSan Diego, California  92123
Northwestern UniversityChicago, Illinois  60611
SUNY Upstate Medical UniversitySyracuse, New York  13210
Augusta Oncology AssociatesAugusta, Georgia  30901
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Mayo ClinicScottsdale, Arizona  
The Cleveland Clinic FoundationCleveland, Ohio  
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
Gabrail Cancer CenterCanton, Ohio  44718
Boca Raton Community HospitalBoca Raton, Florida  33486
Drexel University College of MedicinePhiladelphia, Pennsylvania  19129
Kaiser Permanente Medical GroupPortland, Oregon  97227-1191
Ut Southwestern Medical CenterDallas, Texas  75390
McFarland ClinicAmes, Iowa  50010
Oncology Hematology CareCincinnati, Ohio  45242
Northwest Georgia Oncology Centers, PCMarietta, Georgia  30060
Cancer Center of Central ConnecticutSouthington, Connecticut  
Trilogy Cancer CareWooster, Ohio  44691
The Christ HospitalCincinnati, Ohio  45219
Charleston Hematology Oncology AssociatesCharleston, South Carolina  29403
Lake County Oncology and HematologyThe Villages, Florida  32159
Pacific Coast HematologyFountain Valley, California  92708
Edward Hines Jr. VA HospitalHines, Illinois  60141
North Chicago VA Medical CenterNorth Chicago, Illinois  60064
Hematology Oncology Assoc. of IL.Skokie, Illinois  60076
Cancer Center Inc.New Albany, Indiana  47150
Ochsner Medical InstitutionsNew Orleans, Louisiana  70121
Massachusets General HospitalBoston, Massachusetts  02114
Winthrop University Hospital OncologyMineola, New York  11501
Case Western Reserve University Hospitals of ClevelandCleveland, Ohio  44106
Liberty Hematology OncologyColumbia, South Carolina  29203
Swedish Tumor Institute-Medical OncologySeattle, Washington  98104
Gundersen Lutheran Clinic, Ltd.La Crosse, Wisconsin  54601
Florida Hospital Cancer Institute WatermanTavares, Florida  32778
Floyd Memorial Cancer Center of IndianaNew Albany, Indiana  47150