New Clinical Trial Information: Lucatumumab + Bendamustine

Trial Information: 50 patients are being recruited for a Phase I trial of the new anti-CD40 monoclonal antibody lucatumumab (aka HCD122). Patients must have follicular lymphoma and have become resistant to rituximab following previous therapy. Patients will be given combination therapy of lucatumumab with bendamustine, a relatively new alkylating agent.

Drug Information: Bendamustine

Also known as: Treanda

Canadian Status: Bendamustine is not yet approved in Canada for the treatment of follicular lymphoma. However, it is currently being used in several Canadian clinical trials, including a comparison of rituximab + bendamustine with R-CHOP/R-CVP.

Clinical Trial Information: GA-101 and Bendamustine

Trial Information: This is a Phase III trial recruiting 360 Canadian and American patients with indolent lymphoma, including follicular lymphoma, who have been previously treated and are refractory to rituximab. Patients will be randomized to receive bendamustine monotherapy or bendamustine with GA-101 (B-G).

New Clinical Trial Information: Ofatumumab + Bendamustine

Trial Information: This is an international Phase III trial of ofatumumab. 338 patients with relapsed or refractory indolent lymphoma, including follicular lymphoma, will be randomized to receive either bendamustine monotherapy or ofatumumab plus bendamustine (O-B), in eight 21-day cycles.

Clinical Trial Information: Bendamustine-Rituximab (B-R) (BRIGHT Study)

Trial Information: 436 patients will be randomized to receive either Bendamustine-Rituximab (B-R), or conventional therapy (R-CHOP or R-CVP). This is an international Phase III trial intended to compare the effectiveness of bendamustine with a conventional alkalating agent/anthracycline-based regimen, CHOP (cyclophosphamide, vincristine, prednisone, and doxorubicin) or CVP (cyclophosphamide, vincristine, and prednisone).

This study is recruiting people with follicular lymphoma, mantle call lymphoma, Waldenstrom macroglobulinemia, and marginal zone B-cell lymphomas. This is for patients eligible for first-line treatment, i.e. previously untreated and having one or more criteria for treatment (B symptoms, bulky disease, etc.).

Bendamustine Continues to Impress

This month, some new trial data came available that continues to illustrate the advantages of the "new" alkylating agent bendamustine (Treanda). Bendamustine is a nitrogen mustard agent that was developed in East Germany in the 1960s. Despite being a very old communist drug, it is now a very new capitalist drug, with the price tag and brand name to boot. It's effective enough that there are now a number of trials looking at whether bendamustine can stand in for the more conventional chemotherapy regimens like CHOP (in combination, of course, with new drugs of choice like rituximab).

In Canada, there are currently five ongoing clinical trials involving bendamustine that are looking for test subjects with lymphoma. These include an ofatumumab trial in refractory patients (bendamustine versus O-B), a GA101 study in refractory patients (bendamustine versus B-GA101) the major BRIGHT Study for new patients (B-R going head to head with the older standbys, R-CHOP and R-CVP). A sixth trial is looking at bendamustine in childhood leukemia patients.