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

Phase II Study of Ofatumumab as Front-Line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia
• Intervention / Treatment: Biological: Ofatumumab

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (ofatumumab); Participants receive ofatumumab 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.	Biological: Ofatumumab; Given IV; Other Names: Arzerra; HuMax-CD20; GSK1841157; HuMax-CD20, 2F2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With a Response	Response = (complete response [CR] + partial response [PR]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood.	Up to 3 years, 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Time from date of treatment start until the date of first objective documentation of disease-relapse.	Up to 3 years, 10 months
Participants With a Complete Response (CR)	Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.	Up to 3 years, 10 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2011
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimate): October 3, 2011

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Ofatumumab; Antibodies, Monoclonal
• Other Study ID Numbers: 2011-0520 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2018-01841 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No