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Alkylating agents

Rituxan + Bendamustine + PCI-32765 for Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Kami Maddocks

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of a new drug, PCI-32765, when given with two other drugs to treat patients with NHL that has come back.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to infusion such as fever or chills; low blood counts leading to increased infection risk; liver problems; fatigue; digestive issues like nausea or constipation; muscle and bone pain; and potential heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) as determined by the incidence of dose limiting toxicities (DLT) of BTK inhibitor PCI-32765 when given in combination with rituximab and bendamustine hydrochloride

Secondary study objectives

Correlation of PGx with response and toxicity

Duration of response

Frequency, severity, and relatedness of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bendamustine hydrochloride

2010

Completed Phase 2

~370

rituximab

2000

Completed Phase 3

~2760