Know Cancer

or
forgot password

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 Institute Buffalo, New York  14263
Stanford University Stanford, California  94305
Rush University Medical Center Chicago, Illinois  60612-3824
Hackensack University Medical Center Hackensack, New Jersey  07601
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
The Cleveland Clinic Foundation Cleveland, Ohio  
Karmanos Cancer Institute Detroit, Michigan  48201
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Desert Hematology Oncology Medical Group, Inc. Rancho Mirage, California  92270
Cancer & Blood Disease Center Lecanto, Florida  34461
Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611
Cancer Center of Central Connecticut Southington, Connecticut  
Moores Cancer Center La Jolla, California  92093-0820
Gabrail Cancer Center Research Canton, Ohio  44718
Long Island Jewish Medical Center Biomedical Research Alliance of NY (BRANY) New Hyde Park, New York  11042
Drexel University, College of Medicine Philadelphia, Pennsylvania  19102