Ruxolitinib + CHOP for Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Christina Poh

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with untreated nodal T-follicular helper cell lymphoma. Participants should not have had previous treatments for this condition. Specific eligibility criteria are not provided, but typically include factors like age, overall health status, and the stage of the disease.

Inclusion Criteria

Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)

Absolute neutrophil count (ANC) ≥ 1,000/mm^3

Hemoglobin ≥ 8 g/dL

Exclusion Criteria

I have been diagnosed with cirrhosis.

I have had a blood clot in the past 6 months.

I have not had major surgery in the last 4 weeks.

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• Doxorubicin
• Ruxolitinib
• Vincristine

Trial Overview The trial is testing the safety and effectiveness of ruxolitinib combined with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) in treating nodal TFH cell lymphoma. Ruxolitinib targets proteins that may help cancer cells grow; CHOP drugs work by damaging DNA or inhibiting cell division.

How Is the Trial Designed?

Group I: Treatment (ruxolitinib, CHOP) Experimental Treatment 16 Interventions

See Detailed Description

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+