Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Phase 2

Completed

Conditions: Marginal Zone Lymphoma
Small Lymphocytic Lymphoma
Follicular Lymphoma

Interventions: Drug: ofatumumab

Registration Number: NCT01239394

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ofatumumab	ofatumumab	single-arm, open-label, interventional

Primary Outcome Measures

Name	Time	Method
Efficacy: Complete Response Rate (CRR)	1-month post-treatment	Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR). Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5 cm in greatest diameter)

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	12 months	Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse
Overall Response Rate (ORR)	1-month post-treatment	Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR). Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5cm in greatest diameter) PR = \>=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT
Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia	2 years	Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)

Trial Locations

Locations (3): Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Dana-Farber Cancer Institute
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Boston, Massachusetts, United States