Phase II Trial of Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphomas

NOT ENROLLING
Protocol # :
10-271
Conditions
Follicular Lymphoma
Marginal Zone Lymphoma
Small Lymphocytic Lymphoma
Phase
II
Disease Sites
Non-Hodgkin's Lymphoma
Principal Investigator
Abramson, Jeremy, S.
Site Investigator
Jacobsen, Eric
Joyce, Robin, M.
Schwartz, Joel, H.
Weitzman, James
Site Research Nurses
Fabry, Lisa, B.
Lyons, Hannah, Felton

Trial Description

Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of
cancerous B cells, and then triggering the death of those cells. It is approved by the FDA
for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence
of success in people who's B-cell lymphomas have relapsed after initial treatments. In this
research study we are looking to see if ofatumumab is effective and safe in treating
previously untreated B-cell NHL.

Eligibility Requirements

Inclusion Criteria:

- Histologically confirmed indolent CD20+B-cell NHL of the following histologies:
follicular lymphoma, grades 1-2; Marginal zone lymphoma (extranodal, nodal or
splenic); small lymphocytic lymphoma; low-grade B-cell lymphoma not otherwise
specified with CD20+ expression

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension as 20mm or greater CT scan or MRI

- No previous chemotherapy, antibody therapy or radioimmunotherapy for this disease.
Patients previously treated with external beam radiation alone are eligible

- 18 years of age or older

- Life expectancy of greater than 3 months

- ECOG Performance status of 0, 1 or 2

- Organ function as described in the protocol

- Women of child-bearing potential and men must agree so use adequate contraception
prior to study entry and for the duration of study participation

Exclusion Criteria:

- Prior chemotherapy, antibody therapy or radioimmunotherapy for lymphoma

- Participants may not be receiving any other investigational agent

- Participants with known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ofatumumab

- Prior exposure to ofatumumab or other targeted anti-CD20 therapies including rituximab

- Known HIV positivity

- Positive serology for Hepatitis B

- Positive serology for Hepatitis C

- Participants who are candidates for curative radiotherapy, unless radiation therapy is
considered too toxic (as in abdominal disease), or is refused by the patient

- New York Heart Association Classification III of IV heart disease

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection that is not optimally treated with antibiotics, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study
requirements

- Pregnant or breastfeeding women

- History of a different malignancy are ineligible except for the following
circumstances: Individuals with a history of other malignancy are eligible if they
have been disease-free for at least one year and are deemed by the investigator to be
at low risk for recurrence of that malignancy. Individuals with the following cancers
are eligible even if diagnosed and treated within the past 1 year: localized prostate
cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or
bone scan, cervical cancer in situ, breast ductal carcinoma in situ and non-melanoma
skin cancers.

10-271