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A Phase II Trial Of Ofatumumab In Older (≥70 Years) Patients With Previously Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

Phase 2
70 Years
Not Enrolling
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Low-Grade, Lymphoma, Intermediate-Grade

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Trial Information

A Phase II Trial Of Ofatumumab In Older (≥70 Years) Patients With Previously Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

This multicenter Phase II clinical study will investigate the overall response rate (ORR)
after 2 months of therapy with weekly ofatumumab in older (≥70 years of age) patients with
previously untreated low or intermediate risk indolent NHL (n=37). Secondary objectives
include progression free survival (PFS) at 2 years, and an evaluation of the toxicity and
tolerability of ofatumumab in this population.

We will also evaluate molecular response to ofatumumab by performing PCR analysis for
BCL2/IgH from the peripheral blood.

We will conduct an exploratory analysis of the minimum observed serum concentration (Cmin)
of ofatumumab prior to the last dose and correlate this level with ORR.

This trial includes administration of a Geriatric Assessment (GA) tool which patients will
be asked to complete serially during the trial.

Inclusion Criteria:

- Stage II, III, or IV follicular or marginal zone B-cell CD20+ lymphomas not
previously treated with systemic therapy

- Low/intermediate risk grade 1 or 2 follicular NHL or marginal zone lymphoma defined
by 2004 Follicular Lymphoma International Prognostic Index (FLIPI) scores

- Measurable disease as assessed by 2 dimensional measurement by CT and/or by bone
marrow histopathology.

- Age ≥ 70 years at time of informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Life expectancy of at least 3 months

- Documented negative serologic testing for human immunodeficiency virus (HIV)

- Documented negative serologic testing for Hepatitis B (HB); this is defined as
negative for HBsAg;

- If negative for HBsAg but HBcAb positive (regardless of HBsAb status), an
hepatitis B virus (HBV) DNA test will be performed and must be negative for
eligibility. Those with negative HBV DNA may be included but must undergo HBV DNA PCR
testing every 2 months (see Time and Events table). Prophylactic antiviral therapy
may be initiated at the discretion of the investigator in these patients.

- Adequate bone marrow function (without transfusion support within four weeks of
screening) as demonstrated by:

- Hemoglobin ≥ 8 g/dL

- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3

- Platelet count ≥ 50,000/mm3

- Adequate hepatic and renal function as demonstrated by:

- Aspartate aminotransferase (AST/ALT) ≤ 2.5 × upper limit of normal (ULN)

- Total serum bilirubin ≤ 1.5 × ULN

- Alkaline phosphatase ≤ 2.5 × ULN

- Serum creatinine ≤ 1.5 × ULN

- If sexually active male with female partner of reproductive capability, has agreed to
use a medically accepted form of contraception from time of enrollment to completion
of initial follow-up study visit. Adequate contraception is defined as hormonal birth
control, intrauterine device, double barrier method, or total abstinence.

- Signed an institutional review board (IRB)-approved informed consent document for
this protocol

Exclusion Criteria:

- Prior therapies for lymphoma except involved field radiation therapy

- Prior anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to first
infusion of ofatumumab for any reason

- Evidence of transformation to aggressive lymphoma

- More than 10 x 109/L circulating CD20+ lymphoma cells

- History of previous allergic reactions to compounds of similar biological or chemical
composition as ofatumumab

- Medical or other condition that would represent an inappropriate risk to the patient
or would likely compromise achievement of the primary study objective

- Other past or current malignancies with the exception of:

- Patients who have been free of malignancy for at least 5 years

- Completely resected, non-melanoma skin cancer

- Successfully treated in situ carcinoma

- Patients who have current active hepatic or biliary disease (with exception Gilbert's
syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease
per investigator assessment)

- Treatment with any known non-marketed drug substance or experimental therapy within 5
terminal half lives or 4 weeks prior to first infusion of ofatumumab, whichever is
longer, or currently participating in any other interventional clinical study

- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
antiviral treatment such as, but not limited to, chronic renal infection, chronic
chest infection with bronchiectasis, tuberculosis and active Hepatitis C.

- History of significant cerebrovascular disease in the past 6 months or ongoing event
with active symptoms or sequelae

- Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within six months prior to first infusion of ofatumumab, congestive heart
failure (NYHA III-IV), and arrhythmia (unless controlled by therapy), with the
exception of extra systoles or minor conduction abnormalities.

- Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
psychiatric disease which in the opinion of the investigator may represent a risk for
the patient.

- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In
addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a
HBV DNA test will be performed and if positive the patient will be excluded.

Type of Study:


Study Design:

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

Outcome Measure:

To determine overall response rates (ORR) following ofatumumab treatment in older (≥ 70 years old) patients with previously untreated low or intermediate risk indolent NHL

Outcome Description:

The ORR will be evaluated as the rate of complete responses (CR) + partial responses (PR) as defined by the Revised Response Criteria for Malignant Lymphoma (RRCML)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

LCCC 1018



Start Date:

June 2011

Completion Date:

January 2018

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Lymphoma, Follicular
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Low-Grade
  • Lymphoma, Intermediate-Grade
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkins Lymphoma
  • Elderly
  • Newly Diagnosed
  • Lineberger Comprehensive Cancer Center
  • University of North Carolina
  • Ofatumumab
  • Arzerra
  • Phase 2
  • Geriatric
  • Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone