Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
GlaxoSmithKline
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01239394
First received: November 10, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Marginal Zone Lymphoma
Small Lymphocytic Lymphoma
Drug: ofatumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate.


Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Evaluate safety of ofatumumab monotherapy in this patient population

  • Pharmacodynamics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate pharmacodynamics of B cell depletion

  • Neutropenia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the incidence and duration of neutropenia

  • Hypogammaglobulinemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimate incidence, severity and duration of hypogammaglobulinemia


Estimated Enrollment: 42
Study Start Date: November 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ofatumumab
    Weekly infusion for 8 weeks
    Other Names:
    • GSK1841157
    • HuMax-CD20
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239394

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Jeremy S. Abramson, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01239394     History of Changes
Other Study ID Numbers: 10-271
Study First Received: November 10, 2010
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
NHL
ofatumumab

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014