Clinical trial NCT01444716: Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
Official title: Phase II Study of Ofatumumab as Front-Line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-10-03
Enrollment: 34
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 with the ability of cancer cells to grow and spread.

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 determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients.

II. To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL.

III. To determine the plasma levels of ofatumumab in elderly, unfit patients. IV. To evaluate predictive capability of micro ribonucleic acid (RNA) (miRNAs) detection in plasma samples.

OUTLINE:

Participants receive ofatumumab intravenously (IV) over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

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.

Primary outcomes:
measure: Participants With a Response
timeFrame: Up to 3 years, 10 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 3 years, 10 months
measure: Participants With a Complete Response (CR)
timeFrame: Up to 3 years, 10 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alessandra Ferrajoli
role: PRINCIPAL_INVESTIGATOR
References: