Overview

Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL)

Status:
Active, not recruiting
Trial end date:
0000-00-00
Target enrollment:
34
Participant gender:
Both
Summary
The goal of this clinical research study is to learn if ofatumumab can help to control CLL. The safety of this drug will also be studied. Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the leukemia cells to die.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
GlaxoSmithKline
National Comprehensive Cancer Network
Treatments:
Antibodies, Monoclonal
Last Updated:
2016-12-14
Criteria
Inclusion Criteria:

1. Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of
signing informed consent.

2. The Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO)
performance status of 2-3.or patients with chronic lymphocytic leukemia requiring
treatment age >65 years at the time of signing informed consent and ECOG/WHO
performance status of 0-1 and a CIRS or Charlson co-morbidity score of 2 or higher.

3. Adequate renal and hepatic function (creatinine <2mg/dL and 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:

1. Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the
blood).

2. Known positivity for HIV.

3. Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for
HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be
performed and if positive the subject will be excluded.

4. Prior treatment for chronic lymphocytic leukemia.

5. 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.

6. 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.

7. Any known hypersensitivity to ofatumumab or its components.