Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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 with the ability of cancer cells to grow and spread.

Key facts

Study ID

NCT01444716

Run by

M.D. Anderson Cancer Center

People needed

34

Starts

2011-12-15

Expected to finish

2020-06-11

Last updated by the study team

2021-07-26

Who can join

Age: 66 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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