Actively Recruiting
Ruxolitinib Combined With CHOP Chemotherapy for Untreated Nodal T-Follicular Helper Cell Lymphomas
Led by City of Hope Medical Center · Updated on 2026-06-05
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and optimal dose of ruxolitinib combined with CHOP chemotherapy in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma. This phase I trial aims to determine how well this combination works and to assess the tolerability and preliminary effectiveness, including maintenance therapy with ruxolitinib monotherapy for responders. The study also explores survival outcomes and chemotherapy dose intensity in this patient population. Participants receive ruxolitinib orally twice daily for 21 days along with cyclophosphamide, doxorubicin, vincristine intravenously on day 1, and prednisone orally daily for 5 days per cycle, repeated every 21 days for up to six cycles. Patients who respond to this treatment and are not candidates for stem cell transplantation may continue with ruxolitinib maintenance therapy in 28-day cycles for up to 12 cycles, with the option to extend treatment for another 12 cycles if response remains stable. During the study, participants undergo various assessments including bone marrow biopsies, cardiac scans (MUGA or echocardiography), blood tests, and PET/CT imaging to monitor disease and treatment effects. Researchers will measure the maximum tolerated dose of ruxolitinib, frequency of side effects, response rates, and patient-reported outcomes. After treatment, patients are followed for up to five years to assess long-term safety and effectiveness.
CONDITIONS
Brief Title
Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Age 18 years or older at consent
- Performance status 0-1 on ECOG scale; status 2 allowed if due to lymphoma with principal investigator approval
- Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma, including angioimmunoblastic, nodal PTCL TFH phenotype, or follicular type
- Planned to receive full 6 cycles of chemoimmunotherapy as standard care
- Measurable disease with nodal or extranodal sites or marrow-only disease
- Left ventricular ejection fraction (LVEF) 50% or higher
- Absolute neutrophil count (ANC) 1000/mm³ or greater
- Hemoglobin 8 g/dL or higher
- Platelets 100,000/mm³ or higher (50,000/mm³ allowed with marrow infiltration or hypersplenism)
- Creatinine clearance or GFR 60 mL/min or higher
- Serum total bilirubin less than or equal to 2.0 times upper limit of normal (ULN), with exceptions for liver involvement or Gilbert disease
- AST and ALT less than or equal to 3.0 times ULN (5.0 times ULN if liver involved)
- INR or prothrombin time less than or equal to 1.5 times ULN unless anticoagulated within therapeutic range
- aPTT less than or equal to 1.5 times ULN unless anticoagulated within therapeutic range
- For women of childbearing potential: agree to effective contraception or abstinence during treatment and 4 months after; negative pregnancy test
- For men: agree to abstinence or condom use during treatment and 4 months after; refrain from sperm donation
- Completion of first-line chemotherapy with ruxolitinib and CHOP and documentation of response for consideration of maintenance phase
- Recovery to grade 1 or baseline for prior treatment toxicities except peripheral neuropathy (grade 2 allowed) or alopecia
You will not qualify if you...
- Contraindications to CHOP components or exceeding lifetime anthracycline dose
- Prior systemic treatment or radiation for T-cell lymphoma except limited steroid use for symptom control
- Prior organ transplant
- Known history of cirrhosis
- Current grade greater than 1 peripheral neuropathy or demyelinating Charcot-Marie-Tooth disease
- History of other malignancy affecting study compliance unless treated and in remission or specific low-risk cancers
- Significant uncontrolled cardiovascular or pulmonary disease
- Recent thrombosis within 6 months
- Major surgery within 4 weeks before treatment start except for diagnosis
- Significant abnormal ECG findings
- Active infections requiring systemic treatment including SARS-CoV-2 unless resolved
- Current or history of tuberculosis untreated
- Positive chronic hepatitis B or C infection without appropriate control
- Uncontrolled HIV infection
- Known HTLV 1/2 infection
- Active central nervous system lymphoma
- Pregnancy or breastfeeding or intending pregnancy during study
- Symptomatic gastrointestinal diseases affecting drug absorption
- Use of strong CYP3A inducers or inhibitors within 2 weeks before study intervention
- Receiving other investigational agents
- Any condition or compliance issue that contraindicates participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive ruxolitinib orally twice daily combined with CHOP chemotherapy every 21 days for up to 6 cycles unless disease progression or unacceptable toxicity occurs.
Up to 6 treatment cycles with multiple visits per cycle
Duration - Up to 1 year for initial maintenance, with optional extension up to an additional year
Participants who achieve a response continue with ruxolitinib monotherapy maintenance orally twice daily on days 1-28 of each 28-day cycle for up to 12 cycles, with an optional extension for an additional 12 cycles if response continues.
Up to 12 maintenance cycles with visits every 28 days, plus optional additional cycles
Duration - Up to 5 years
After completion of study treatment, participants are followed up for safety and outcomes including survival for up to 5 years.
Initial follow-up visit at 30 days post-treatment, then periodic visits during long-term follow-up
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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