CompletedPhase 2

Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma

United States135 participantsStarted 2011-04-28

Plain-language summary

This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride with or without bortezomib works in treating patients with untreated follicular non-Hodgkin lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with bortezomib in treating patients with follicular non-Hodgkin lymphoma.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed follicular non-Hodgkin lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (\> 15 centroblasts per high-power field with centrocytes present) * Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies * Fine-needle aspirates are not acceptable * Failure to submit pathology within 60 days of patient registration will be considered a major protocol violation * Patients must have at least one of the following indicators of poor risk disease: * \>= 3 risk factors by the Follicular Lymphoma International Prognostic Index, or 2 risk factors by the Follicular Lymphoma International Prognostic Index and at least one bulky mass or lymph node \> 6 cm in size * Follicular Lymphoma International Prognostic Index (FLIPI score): * Age \> 60 years * Involvement of \> 4 nodal sites * Stage III-IV disease * Hemoglobin \< 12.0 g/dL * Lactate dehydrogenase (LDH) \> upper limit of normal (ULN) * 0-1 of the above risk factors: low risk * 2 risk factors: intermediate risk * \>= 3 risk factors: poor risk * No prior cytotoxic chemotherapy, radiotherapy, immunotherapy, or radioimmunotherapy * No corticosteroids are permitted, except for maintenance therapy for a non-malignant disease or to prevent treatment-related ofatumumab reactions (maintenance therapy dose must not exceed 20 mg/day prednisone or equi…

What they're measuring

Complete Response Rate

Timeframe: From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization

Trial details

NCT IDNCT01286272

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-05-24

Results submitted2018-10-12