CALGB 50901: A Phase II Trial of Ofatumumab (CALGB IND #112390) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

Study Status

Open to Enrollment

Study Description

This is a clinical trial for patients with follicular non-Hodgkin lymphoma (NHL) who have not been previously treated. The purpose of the study is to determine how well patients with follicular NHL respond to treatment with the drug ofatumumab.

Ofatumumab is an antibody therapy that is targeted to attack the abnormal cancer cells that make up follicular lymphoma by recognizing a protein on the surface of these cells. Ofatumumab is an effective treatment for follicular lymphoma and chronic lymphocytic leukemia that comes back after people first respond to other chemotherapy. It is not known how well ofatumumab will work in patients with follicular lymphoma who have not been previously treated.

All patients in the study will receive ofatumumab. You will be randomly assigned to receive one of two doses of ofatumumab; neither you nor the study physician can choose which dose you receive. You will receive either 500 mg or 1000 mg of the study drug via infusion on days 1, 8, 15 and 22 during the first 4 weeks of treatment (induction therapy). Following induction therapy ofatumumab will be given every other month to cover a total of 9 months. During this time you will continue to receive the same dose, either 500 mg or 1000 mg, that you were initially assigned.

We expect patients to be receiving treatment in the study for approximately 9 months. After completing study treatment you will be asked to return for follow-up tests 11, 15, 19, 23, 27, 31, and 35 months after entering the study, and then every 6 months for a maximum of 10 years from study entry, unless your disease should return.

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Disease Status and/or Stage

Untreated Follicular Lymphoma

Sponsor

CALGB

Key Eligibility

  • Men and women age 18 or older
  • Follicular non-Hodgkin lymphoma (NHL)
  • No prior therapy for NHL including chemotherapy or immunotherapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Peter Martin, MD

Contact

Protocol ID

CALGB 50901

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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