Status:
COMPLETED
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
66+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere...
Detailed Description
PRIMARY OBJECTIVES I. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. To deter...
Eligibility Criteria
Inclusion
- Patients with chronic lymphocytic leukemia requiring treatment at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 2-3 and a Cumulative Illness Rating Scale (CIRS) or Charlson co-morbidity score of 2 or higher.
- Creatinine \< 2mg/dL.
- Estimated glomerular filtration rate (eGFR) more than 30cc/minute.
- Bilirubin \< 2mg/dL.
- Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman.
- Patients with Gilbert's syndrome are eligible.
Exclusion
- Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
- Known positivity for human immunodeficiency virus (HIV).
- Hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg). In addition, if negative for HGsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded.
- Prior treatment for chronic lymphocytic leukemia.
- Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
- Any known hypersensitivity to ofatumumab or its components.
Key Trial Info
Start Date :
December 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01444716
Start Date
December 15 2011
End Date
June 11 2020
Last Update
July 26 2021
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030