Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia



Status:Completed
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:October 19, 2009
End Date:September 5, 2017

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A Phase 2, Multi-Center, Randomized, Double-Blinded, 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

The purpose of this study is to determine the safety and effectiveness of different dose
regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia
(CLL).


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
We found this trial at
17
sites
Winston-Salem, North Carolina 26157
306
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Winston-Salem, NC
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
295
mi
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Buffalo, NY
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
2100
mi
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Stanford, CA
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103
mi
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Canton, OH
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
277
mi
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Chicago, IL
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274
mi
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
138
mi
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Cleveland, OH
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Detroit, Michigan 48201
164
mi
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Detroit, MI
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Edmonton, Alberta
1700
mi
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Edmonton,
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
476
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Hackensack, NJ
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Indianapolis, Indiana 46202
167
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Indianapolis, IN
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La Jolla, California 92093
1926
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La Jolla, CA
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Lecanto, Florida 34461
768
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Lecanto, FL
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494
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New Hyde Park, NY
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416
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Philadelphia, PA
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1884
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Rancho Mirage, CA
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Southington, Connecticut 06489
542
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Southington, CT
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