CALGB 50904: A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib (NSC #681239, IND #58443) and Bendamustine in Patients with Untreated Follicular Lymphoma

Study Status

Open to Enrollment

Study Description

This is a clinical trial for people who have been diagnosed with follicular lymphoma and who have not received prior treatment.

The purpose of the study is to determine how well people with follicular lymphoma respond to treatment with a combination of the drugs ofatumumab and bendamustine, compared to the combination of ofatumumab, bendamustine, and bortezomib. The combination of these drugs has not been approved by the FDA; therefore; the use of this combination of drugs is considered experimental.

Study participants will be randomly assigned to 1 of 2 study groups:

  • Group A: ofatumumab and bendamustine for up to 6 treatment cycles. After completing the 6 cycles, participants can continue to receive ofatumumab by itself for another 4 treatment cycles.
  • Group B: ofatumumab, bendamustine and bortezomib for up to 6 treatment cycles. After completing the 6 treatments, participants can continue to receive ofatumumab with bortezomib for another 4 treatment cycles.

Study participants in both treatment groups will take induction treatment for 7 months, and the maintenance period will last for 8 months. After completing maintenance treatment, participants will be asked to return to the clinic for follow-up every 4 months for the first 2 years, and then every 6 months for up to 10 years.

Disease Status and/or Stage

Untreated Follicular Lymphoma

Sponsor

CALGB

Key Eligibility

  • Men and women age 18 and older
  • Diagnosed with follicular non-Hodgkin lymphoma
  • No prior chemotherapy, radiotherapy, immunotherapy or radioimmunotherapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Peter Martin, MD

Contact

Protocol ID

CALGB 50904

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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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