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A Phase II, Multi-center, Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Different Lenalidomide (Revlimid) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Phase II, Multi-center, Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Different Lenalidomide (Revlimid) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Age ≥ 18 years at the time of signing the informed consent form

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

- Must have a documented diagnosis of B-cell CLL

- Must be relapsed or refractory to at least 1 regimen for treatment of CLL . At least
one of the prior treatments must have included a purine analog-based or
bendamustine-based regimen

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

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Active infections requiring systemic antibiotics

- Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide
treatment

- Alemtuzumab therapy within 120 days of initiating lenalidomide treatment

- Prior therapy with lenalidomide

- History of grade 4 rash due to prior thalidomide treatment

- Planned autologous or allogeneic bone marrow transplantation

- Central nervous system (CNS) involvement as documented by spinal fluid cytology or
imaging.

- Uncontrolled hyperthyroidism or hypothyroidism

- Venous thromboembolism within 12 months

- ≥ Grade-2 neuropathy

- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

- Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic
leukemia]

- Participation in any clinical study or having taken any investigational therapy
within 28 days prior to initiating lenalidomide therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide]

Outcome Time Frame:

24 months post LPFV

Safety Issue:

Yes

Principal Investigator

Jay Mei, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-CLL-009

NCT ID:

NCT00963105

Start Date:

July 2009

Completion Date:

March 2013

Related Keywords:

  • Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Stanford UniversityStanford, California  94305
Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
The Cleveland Clinic FoundationCleveland, Ohio  
Karmanos Cancer InstituteDetroit, Michigan  48201
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
Cancer & Blood Disease CenterLecanto, Florida  34461
Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611
Cancer Center of Central ConnecticutSouthington, Connecticut  
Moores Cancer CenterLa Jolla, California  92093-0820
Gabrail Cancer Center ResearchCanton, Ohio  44718
Long Island Jewish Medical Center Biomedical Research Alliance of NY (BRANY)New Hyde Park, New York  11042
Drexel University, College of MedicinePhiladelphia, Pennsylvania  19102