Phase 2
Completed N=34
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT01444716 ↗Enrolled (actual)
34
Serious AEs
26.5%
Results posted
Jul 2021
Primary outcomePrimary: Participants With a Response — 23 Participants
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 with the ability of cancer cells to grow and spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Response |
23 | — |
| SECONDARY Progression-free Survival (PFS) |
21 | — |
| SECONDARY Participants With a Complete Response (CR) |
6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01444716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.