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

Phase 2
18 Years
Open (Enrolling)
Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma

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Trial Information

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

- 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

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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jeremy S. Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • NHL
  • ofatumumab
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617