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Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy

Phase 3
18 Years
Open (Enrolling)
Lymphoma, Follicular

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Trial Information

Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy

Inclusion Criteria:

1. Follicular lymphoma (FL); grades 1, 2 and 3A, defined according to World Health
Organization guidelines.

2. Rituximab-sensitive FL, defined as a partial or complete response to treatment with
rituximab or a rituximab-containing regimen lasting at least 6 months following
completion of the last rituximab treatment.

3. Relapse or disease progression following response to prior rituximab-based therapy,
as defined by 2007 Revised Response Criteria for Malignant Lymphoma criteria, which
requires therapy.

4. Radiographically measurable disease, defined as at least one clearly demarcated
lesion with a largest diameter ≥ 2.0 cm by CT scan imaging.

5. ECOG Performance Status of 0, 1, or 2.

6. Age ≥ 18 years.

7. Life expectancy of at least 6 months in the opinion of the investigator.

8. The patient or their legally acceptable representative must be capable of giving
written informed consent prior to performing any study-specific tests or procedures.

9. All prior treatment related non-hematologic toxicities (with the exception of
alopecia) must have resolved to CTCAE (Version 4.0) ≤ Grade 2 at the time of

French subjects: In France, a subject will be eligible for inclusion in this study only if
either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

1. Previous treatment with ofatumumab.

2. Previous radioimmunotherapy (RIT) within 6 months of randomization. Patients who
have received previous RIT must have attained a partial or complete response lasting
at least 6 months, and must have recovered from any hematologic or other toxicity.

3. Previous autologous stem cell transplantation within 6 months of randomization.

4. Previous allogeneic stem cell transplantation.

5. Previous anti-lymphoma monoclonal antibody therapy (excluding rituximab),
chemotherapy, glucocorticoid, or other systemic therapy for lymphoma within 3 months
of randomization.

6. Current or previous participation in another interventional clinical study within 4
weeks of randomization.

7. Current or previous other malignancy within 2 years of randomization. Subjects who
have been free of malignancy for at least 2 years, or have a history of completely
resected non-melanoma skin cancer or successfully treated carcinoma in situ, are

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

9. Clinically significant cardiac disease as judged by the investigator including
unstable angina, acute myocardial infarction within 6 months of randomization,
congestive heart failure, and arrhythmia requiring therapy.

10. Other significant concurrent, uncontrolled medical conditions including, but not
limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine,
pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's
opinion, will impact study participation.

11. Screening laboratory values:

1. Neutrophils < 1.5 x 109/L (unless due to FL involvement of the bone marrow).

2. Platelets < 50 x 109/L (unless due to FL involvement of the bone marrow).

3. ALT or AST > 2xULN, alkaline phosphatase and bilirubin > 1.5xULN (isolated
predominantly indirect hyperbilirubinemia due to Gilbert's syndrome is
acceptable for inclusion)

12. Known or suspected inability to fully comply with study protocol

a. Lactating women. b. Women with a positive pregnancy test at study entry c. Men with
partners of childbearing potential and women of childbearing potential who are not willing
to use adequate contraception from study entry through one year following last treatment

14. Current active liver or biliary disease (with the exception of Gilbert's syndrome or
asymptomatic gallstones).

15. 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 HB DNA
test will be performed and if positive the subject will be excluded.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

200 weeks

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Slovakia: State Institute for Drug Control

Study ID:




Start Date:

October 2010

Completion Date:

June 2019

Related Keywords:

  • Lymphoma, Follicular
  • Follicular Lymphoma
  • Randomized trial
  • Ofatumumab
  • Rituximab
  • Lymphoma
  • Lymphoma, Follicular



GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteFargo, North Dakota  58103
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSeattle, Washington  98133