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

Completed · Phase 2

Conditions studied: Relapsed or Refractory Chronic Lymphocytic Leukemia

In brief

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).

Key facts

Study ID

NCT00963105

Run by

Celgene

People needed

104

Starts

2009-10-19

Expected to finish

2017-09-05

Last updated by the study team

2018-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Desert Hematology Oncology Medical Group, Inc. — Rancho Mirage, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Cancer and Blood Disease Center — Lecanto, Florida, United States
• Northwestern University Medical Center Division of Hematology Oncology — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Long Island Jewish Medical Center CLL Research and Treatment Program — New Hyde Park, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Drexel University, College of Medicine, Clinical Research Group — Philadelphia, Pennsylvania, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• CHU Sud — Amiens, France
• Hopital Avicenne — Bobigny, France
• CHU Grenoble — Grenoble, France
• Clinique Victor Hugo — Le Mans, France
• Institut Paoli Calmettes — Marseille, France
• CHU Montpellier - Hôpital Saint Eloi — Montpellier, France
• Hopital Emile Muller — Mulhouse, France
• UCSD Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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