Rituxan + Bendamustine + PCI-32765 for Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kami Maddocks

Must not be taking: QTc prolonging drugs

Disqualifiers: Cardiovascular disease, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

48 Participants Needed

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.

Research Team

Kami Maddocks, MD

Principal Investigator

Ohio State University

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.

Inclusion Criteria

My body weight is at least 40 kg.

Agreement to use contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear children

Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty

Exclusion Criteria

I have had cancer before, but I've been cancer-free for at least 2 years, or it won't shorten my life expectancy.

I don't have any severe illnesses that could affect my safety or the study's results.

I have experienced significant side effects from cancer treatment, excluding hair loss.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BTK inhibitor PCI-32765 orally once daily on days 1-28, rituximab intravenously on day 1, and bendamustine hydrochloride intravenously on days 1-2. Treatment repeats every 28 days for up to 6 courses.

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 4 months for up to 2 years.

up to 24 months

Treatment Details

Interventions

• Bendamustine Hydrochloride
• PCI-32765
• Rituximab

Trial Overview 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.

Participant Groups

Group I: Treatment (enzyme inhibitor, chemo, monoclonal antibody) Experimental Treatment 6 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:

• Chronic lymphocytic leukemia (CLL)
• Non-Hodgkin lymphoma (NHL)

Approved in European Union as Levact for:

• Chronic lymphocytic leukemia (CLL)
• Non-Hodgkin lymphoma (NHL)
• Multiple myeloma

Approved in Japan as Ribomustin for:

• Chronic lymphocytic leukemia (CLL)
• Non-Hodgkin lymphoma (NHL)

Who Is Running the Clinical Trial?

Kami Maddocks

Lead Sponsor

Trials

4

Recruited

220+

Kami Maddocks, MD

Lead Sponsor

Trials

3

Recruited

220+

Pharmacyclics LLC.

Industry Sponsor

Trials

114

Recruited

13,800+

Dr. Maky Zanganeh

Pharmacyclics LLC.

Chief Executive Officer

Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France

Dr. Ellie Im

Pharmacyclics LLC.

Chief Medical Officer

MD from an unspecified institution