Know Cancer

or
forgot password

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 University Winston-Salem, North Carolina  27103
Roswell Park Cancer Institute Buffalo, New York  14263
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
New York Medical College Valhalla, New York  10595
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Rush University Medical Center Chicago, Illinois  60612-3824
Hackensack University Medical Center Hackensack, New Jersey  07601
Nevada Cancer Research Foundation Las Vegas, Nevada  89109
Long Island Jewish Medical Center New Hyde Park, New York  11040
University of Colorado Denver, Colorado  80217
Kaiser Permanente Medical Group Los Angeles, California  90027
Abington Hematology Oncology Associates Meadowbrook, Pennsylvania  18974
Stanford Cancer Center Stanford, California  94305-5824
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Sharp Memorial Hospital San Diego, California  92123
Northwestern University Chicago, Illinois  60611
SUNY Upstate Medical University Syracuse, New York  13210
Augusta Oncology Associates Augusta, Georgia  30901
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Mayo Clinic Scottsdale, Arizona  
The Cleveland Clinic Foundation Cleveland, Ohio  
Hematology Oncology Consultants, Inc. Columbus, Ohio  43235
Gabrail Cancer Center Canton, Ohio  44718
Boca Raton Community Hospital Boca Raton, Florida  33486
Drexel University College of Medicine Philadelphia, Pennsylvania  19129
Kaiser Permanente Medical Group Portland, Oregon  97227-1191
Ut Southwestern Medical Center Dallas, Texas  75390
McFarland Clinic Ames, Iowa  50010
Oncology Hematology Care Cincinnati, Ohio  45242
Northwest Georgia Oncology Centers, PC Marietta, Georgia  30060
Cancer Center of Central Connecticut Southington, Connecticut  
Trilogy Cancer Care Wooster, Ohio  44691
The Christ Hospital Cincinnati, Ohio  45219
Charleston Hematology Oncology Associates Charleston, South Carolina  29403
Lake County Oncology and Hematology The Villages, Florida  32159
Pacific Coast Hematology Fountain Valley, California  92708
Edward Hines Jr. VA Hospital Hines, Illinois  60141
North Chicago VA Medical Center North Chicago, Illinois  60064
Hematology Oncology Assoc. of IL. Skokie, Illinois  60076
Cancer Center Inc. New Albany, Indiana  47150
Ochsner Medical Institutions New Orleans, Louisiana  70121
Massachusets General Hospital Boston, Massachusetts  02114
Winthrop University Hospital Oncology Mineola, New York  11501
Case Western Reserve University Hospitals of Cleveland Cleveland, Ohio  44106
Liberty Hematology Oncology Columbia, South Carolina  29203
Swedish Tumor Institute-Medical Oncology Seattle, Washington  98104
Gundersen Lutheran Clinic, Ltd. La Crosse, Wisconsin  54601
Florida Hospital Cancer Institute Waterman Tavares, Florida  32778
Floyd Memorial Cancer Center of Indiana New Albany, Indiana  47150