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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07278856
Phase
PHASE1
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Computed Tomography — PROCEDURE
    Undergo CT and FDG-PET/CT
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • FDG-Positron Emission Tomography — PROCEDURE
    Undergo FDG-PET/CT
  • Filgrastim — BIOLOGICAL
    Given SC
  • Fludeoxyglucose F-18 — OTHER
    Given FDG
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Pegfilgrastim — BIOLOGICAL
    Given SC
  • Prednisone — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Ruxolitinib Phosphate — DRUG
    Given PO
  • Vincristine — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ruxolitinib, CHOP)
    See Detailed Description

Primary Outcome Measure

Maximum tolerated dose (MTD) of ruxolitinib when given in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy [ Time Frame: Prior to cycle 2 day 1 (cycle length = 21 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Christina Poh
[email protected]
626-256-4673
Christina Poh (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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