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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ofatumumab
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ofatumumab)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free Survival (PFS)
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Participants With a Complete Response (CR)
Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.

Full Information

First Posted
September 28, 2011
Last Updated
July 22, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01444716
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2011 (Actual)
Primary Completion Date
June 11, 2020 (Actual)
Study Completion Date
June 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ofatumumab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Ofatumumab
Other Intervention Name(s)
Arzerra, GSK1841157, HuMax-CD20, HuMax-CD20, 2F2
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Participants With a Response
Description
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.
Time Frame
Up to 3 years, 10 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time Frame
Up to 3 years, 10 months
Title
Participants With a Complete Response (CR)
Description
Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.
Time Frame
Up to 3 years, 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Ferrajoli
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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