Rituxan + Bendamustine + PCI-32765 for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByKami Maddocks, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Kami Maddocks

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine hydrochloride may kill more cancer cells.

Eligibility Criteria

This trial is for adults with certain types of B-cell non-Hodgkin lymphoma that have come back after treatment. They must weigh at least 40 kg, be fairly active (ECOG <=2), and agree to use birth control if they can have children. People who've had other cancers recently, serious illnesses, or major surgery aren't eligible. Also excluded are those with HIV/HBV/HCV infections, severe heart disease, or poor kidney/liver/blood function.

Participant Groups

The trial tests a combination of treatments: the BTK inhibitor PCI-32765 with rituximab and bendamustine hydrochloride in patients whose lymphoma has returned. It aims to find the safest dose that works best by blocking cancer cell growth enzymes and attacking cancer cells directly.

1Treatment groups

Experimental Treatment

Group I: Treatment (enzyme inhibitor, chemo, monoclonal antibody)Experimental Treatment6 Interventions

Patients receive BTK inhibitor PCI-32765 PO QD on days 1-28. Patients also receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue receiving BTK inhibitor PCI-32765 PO in the absence of disease progression or unacceptable toxicity.

Bendamustine Hydrochloride is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as Treanda for: