Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Marginal Zone Lymphoma

Small Lymphocytic Lymphoma

Follicular Lymphoma

Treatments

Drug: ofatumumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01239394

10-271

Details and patient eligibility

About

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.

Full description

Participants will receive ofatumumab once a week for 8 weeks by intravenous infusion (Days 1, 8, 15, 22, 29, 36, 43, and 50).
Participants will be seen weekly during the 8 week treatment period and will have the following tests and procedures performed: Blood tests, performance status and physical examination.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.