Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
Completed · Phase 3
Conditions studied: B-Cell Chronic Lymphocytic Leukemia
In brief
The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.
Key facts
- Study ID
- NCT00910910
- Run by
- Celgene
- People needed
- 450
- Starts
- 2009-10-13
- Expected to finish
- 2018-05-09
- Last updated by the study team
- 2019-07-09
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must sign an informed consent form.
- Age ≥ 65 years
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of B-cell CLL.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
- Must agree to follow pregnancy precautions as required by the protocol.
- Must agree to receive counseling related to teratogenic and other risks of lenalidomide.
- Must agree not to donate blood or semen as defined by the protocol
You may not qualify if…
- Prior treatment for B-cell CLL.
- Any medical condition, that would prevent the subject from signing the informed consent form.
- Active infections requiring systemic antibiotics.
- Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
- Pregnant or lactating females.
- Participation in any clinical study or having taken any investigational therapy within 28 days.
- Known presence of alcohol and/or drug abuse.
- Central nervous system (CNS) involvement.
- 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)
- History of renal failure requiring dialysis.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
- Prior therapy with lenalidomide.
- Evidence of TLS at screening
- Presence of specific hematology and/or chemistry abnormalities
- Uncontrolled hyperthyroidism or hypothyroidism
- Venous thromboembolism within one year
- ≥ Grade-2 neuropathy
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
Where it is running
- Innovative Clinical Research Institute — Whittier, California, United States
- The Hospital of Central Connecticut — New Britain, Connecticut, United States
- Cancer Center of Central Connecticut — Southington, Connecticut, United States
- University Hematology Oncology Inc. — Centralia, Illinois, United States
- North Chicago VA Medical Center — North Chicago, Illinois, United States
- Medical Consultants, PC — Muncie, Indiana, United States
- Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services — New Albany, Indiana, United States
- Purchase Cancer Group — Paducah, Kentucky, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Saint Louis University Cancer Center — St Louis, Missouri, United States
- Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
- Oncology and Hematology Associates, PA — Denville, New Jersey, United States
- The Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
- Somerset Hematology-Oncology Associates — Somerville, New Jersey, United States
- Roswell Park Cancer Center — Buffalo, New York, United States
- New York Medical College — Valhalla, New York, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
- Drexel University, College of Medicine — Philadelphia, Pennsylvania, United States
- Pottstown Memorial Medical Center — Pottstown, Pennsylvania, United States
- Berks Hematology-Oncology Associates — West Reading, Pennsylvania, United States
- Geisinger Health System — Wilkes-Barre, Pennsylvania, United States
- Charleston Hematology Oncology P.A. — Charleston, South Carolina, United States
- South Carolina Cancer Specialists — Hilton Head Island, South Carolina, United States
- Central Texas Veterans Health Care System — Temple, Texas, United States
- California Cancer Associates for Research and Excellence cCARE — Escondido, California, United States
Full record on ClinicalTrials.gov
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