Clinical Trial: Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

  • 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.

Sponsor: Massachusetts General Hospital

Current Primary Outcome: Efficacy: Complete Response Rate (CRR) [ Time Frame: 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)



Original Primary Outcome: Efficacy [ Time Frame: 2 years ]

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


Current Secondary Outcome:

  • Overall Response Rate (ORR) [ Time Frame: 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

  • Progression-free Survival (PFS) [ Time Frame: 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
  • Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia [ Time Frame: 2 years ]
    Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)


Original Secondary Outcome:

  • Safety [ Time Frame: 2 years ]
    Evaluate safety of ofatumumab monotherapy in this patient population
  • Pharmacodynamics [ Time Frame: 2 years ]
    Evaluate pharmacodynamics of B cell depletion
  • Neutropenia [ Time Frame: 2 years ]
    Evaluate the incidence and duration of neutropenia
  • Hypogammaglobulinemia [ Time Frame: 2 years ]
    Estimate incidence, severity and duration of hypogammaglobulinemia


Information By: Massachusetts General Hospital

Dates:
Date Received: November 10, 2010
Date Started: December 2010
Date Completion: December 2017
Last Updated: March 17, 2017
Last Verified: March 2017