Parsaclisib + Standard Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Yucai Wang, M.D., Ph.D. - Doctors and ...

Overseen byYucai Wang

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called parsaclisib, sometimes combined with polatuzumab-vedotin, along with standard cancer drugs in patients with high-risk diffuse large B-cell lymphoma. Parsaclisib blocks enzymes that help cancer grow, while polatuzumab-vedotin targets and kills cancer cells. The goal is to see if this combination works better than the standard treatment alone.

Research Team

Yucai Wang

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults with newly diagnosed, high risk diffuse large B-cell lymphoma. Participants must have certain types of this cancer (non-GCB subtype or express specific proteins), be in specific stages, and have a good performance status. They need normal organ function tests and agree to use birth control if applicable. Excluded are pregnant individuals, those with uncontrolled illnesses, HIV on antiretroviral therapy, prior CNS lymphoma involvement, severe lung disease or heart failure.

Inclusion Criteria

Measurable disease as detected by computed tomography (CT) or PET/CT

I am 18 years old or older.

Negative urine pregnancy test done =< 7 days prior to registration for persons of childbearing potential

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Exclusion Criteria

Nursing persons

I have not had a heart attack in the last 6 months.

I do not have any uncontrolled illnesses.

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Treatment Details

Interventions

Cyclophosphamide (Chemotherapy)
Doxorubicin Hydrochloride (Chemotherapy)
Parsaclisib (PI3K Inhibitor)
Pegfilgrastim (Other)
Polatuzumab Vedotin (Monoclonal Antibodies)
Prednisone (Other)
Rituximab (Monoclonal Antibodies)
Vincristine Sulfate (Chemotherapy)

Trial OverviewThe trial is testing the effectiveness of parsaclisib with or without polatuzumab vedotin plus standard R-CHOP therapy against R-CHOP alone. Parsaclisib inhibits enzymes for cell growth; polatuzumab delivers chemo directly to cancer cells; R-CHOP includes rituximab and various chemotherapy drugs aimed at stopping cancer spread.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (parsaclisib, R-CHOP)Experimental Treatment7 Interventions

Patients receive parsaclisib PO QD on days 1-10 or 1-14, rituximab IV or biosimilar substitute, cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV over 15 minutes on day 1. Patients also receive prednisone PO on days 1-5 and pegfilgrastim SC or biosimilar substitute on day 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (parsaclisib, R-CHOP, polatuzumab vedotin)Active Control8 Interventions

Patients receive parsaclisib PO once daily QD on days 1-10 or 1-14, polatuzumab vedotin IV over 90 minutes, rituximab IV or biosimilar substitute, cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV over 15 minutes on day 1. Patients also receive prednisone PO on days 1-5 and pegfilgrastim SC or biosimilar substitute on day 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Cyclophosphamide is already approved in Canada, Japan for the following indications: