Status:
COMPLETED
Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
Lead Sponsor:
Celgene
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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 eff...
Detailed Description
After notification from the US Food and Drug Administration (FDA) on 12 July 2013, Celgene agreed to discontinue the lenalidomide treatment for all patients due to an imbalance in the number of deaths...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\]
Key Trial Info
Start Date :
October 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2018
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00910910
Start Date
October 13 2009
End Date
May 9 2018
Last Update
July 9 2019
Active Locations (165)
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1
California Cancer Associates for Research and Excellence cCARE
Escondido, California, United States, 92025
2
Innovative Clinical Research Institute
Whittier, California, United States, 90603
3
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
4
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489