Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas

Summary

This phase I trial tests the safety, side effects and best dose of ruxolitinib in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy and how well the combination works in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma. Ruxolitinib phosphate blocks a protein called janus kinase, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response. Ruxolitinib phosphate is a type of tyrosine kinase inhibitor. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Doxorubicin is a type of anthracycline antitumor antibiotic. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving ruxolitinib in combination with CHOP chemotherapy may be safe, tolerable, and/or effective in treating patients with untreated nodal TFH cell lymphoma.

Conditions

• Follicular Helper T-Cell Lymphoma
• Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
• Follicular Helper T-Cell Lymphoma, Follicular-Type
• Follicular Helper T-Cell Lymphoma, Not Otherwise Specified
• Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Peripheral T-Cell Lymphoma, Not Otherwise Specified

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Computed Tomography

Undergo CT and FDG-PET/CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET/CT

BIOLOGICAL

Filgrastim

Given SC

OTHER

Fludeoxyglucose F-18

Given FDG

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Pegfilgrastim

Given SC

DRUG

Prednisone

Given PO

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Ruxolitinib Phosphate

Given PO

DRUG

Vincristine

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Christina Poh · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-27

Primary Completion

2027-03-31

Completion

2027-03-31

FDA Drug

Yes

Countries

• United States

Study Locations