Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma

Summary

This phase I/Ib trial studies the side effects and best dose of parsaclisib with or without polatuzumab-vedotin (Pola) plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone \[PaR-CHOP\]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab-vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as anti-CD79b receptors, and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.

Conditions

• Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage II Follicular Lymphoma
• Ann Arbor Stage II Marginal Zone Lymphoma
• Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage III Follicular Lymphoma
• Ann Arbor Stage III Marginal Zone Lymphoma
• Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage IV Follicular Lymphoma
• Ann Arbor Stage IV Marginal Zone Lymphoma
• Diffuse Large B-Cell Lymphoma
• High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
• High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Indolent Non-Hodgkin Lymphoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Parsaclisib

Given PO

BIOLOGICAL

Pegfilgrastim

Given SC

DRUG

Polatuzumab Vedotin

Given IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Yucai Wang, M.D., Ph.D. · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-15

Primary Completion

2023-10-04

Completion

2028-05-16

FDA Drug

Yes

Countries

• United States

Study Locations