Actively Recruiting
A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed/Refractory T-cell Lymphoma and 9p Amplified Lymphomas
Led by Seda S. Tolu · Updated on 2025-12-16
53
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Seda S. Tolu
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether adding the drug ruxolitinib to the immunotherapy pembrolizumab is safe and effective for treating relapsed or refractory types of T-cell lymphoma, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), and other lymphomas such as Hodgkin Lymphoma (HL), Gray Zone Lymphoma (GZL), and Primary Mediastinal B-cell Lymphoma (PMBCL). The goal is to see how many patients achieve complete remission or show improvement with this combination treatment. This is a phase II clinical trial exploring new options for lymphomas that have returned or not responded to previous chemotherapy. Participants will receive ruxolitinib orally at a dose of 20 mg twice daily for up to 12 months, until the disease progresses, or side effects become intolerable. Pembrolizumab will be given intravenously at 200 mg every 21 days for up to 12 months or 17 treatment cycles. After finishing ruxolitinib treatment, doctors will continue to monitor patients for side effects and disease status for an additional year. Throughout the study, patients will undergo scans such as PET-CT or contrast-enhanced CT or MRI to measure disease response. Researchers will track outcomes like the rate of complete remission and overall response to treatment over 24 months. Safety checks, blood tests, and assessments of organ function will be performed regularly. Patients will be closely followed for side effects during and after treatment to ensure ongoing safety and well-being.
CONDITIONS
Brief Title
Amping up With PemJAK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed or refractory Hodgkin Lymphoma, Primary Mediastinal B-cell Lymphoma, Gray Zone Lymphoma, or T-cell lymphomas including specific subtypes
- Received at least one prior systemic therapy; prior CD30-directed therapy required for systemic ALCL and certain PTCL subtypes
- No chemotherapy or immunotherapy within 2 weeks before study entry and recovered from adverse events to grade 1 or less
- Age 18 years or older
- Measurable disease with recent PET-CT (within 4 weeks) or contrast-enhanced CT/MRI
- No active central nervous system disease; treated and asymptomatic patients allowed
- Screening for hepatitis B with appropriate prophylaxis if positive
- Treated and cured hepatitis C infection or undetectable viral load if on treatment
- HIV-positive patients on effective therapy with undetectable viral load within 26 weeks
- Adequate organ function and ECOG performance status 0-2 or Karnofsky score 50 or higher
- Willingness and ability to provide informed consent
- Women of childbearing potential and men must agree to use contraception during and 6 months after treatment
- Women must not be pregnant or breastfeeding
You will not qualify if you...
- Diagnosis of Adult T-Cell Leukemia/Lymphoma (ATLL)
- History of autoimmune disease requiring systemic treatment
- Immunodeficiency or immunosuppressive therapy within 7 days before first dose
- Ongoing systemic steroids above 10 mg prednisone daily or equivalent
- Patients eligible for autologous stem cell transplant or CAR-T (for HL and PMBCL)
- Progression after allogeneic stem cell transplantation unless approved case-by-case
- History of solid organ transplant requiring active immunosuppression
- Active tuberculosis at screening
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab or ruxolitinib
- Inability to swallow or take oral medications
- Pregnancy, breastfeeding, or planning to conceive during study and up to 120 days after last dose
- Concurrent active malignancy under treatment
- Recent major cardiac events within 6 months except manageable events
- Active uncontrolled infections at screening except localized or treated infections meeting criteria
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.
Duration - Up to 12 months or until disease progression or intolerable side effects
Participants receive the study drugs ruxolitinib and pembrolizumab. Ruxolitinib is taken orally twice daily, and pembrolizumab is given intravenously every 21 days. Treatment continues as long as the disease responds, up to a maximum of one year (or 17 cycles).
Pembrolizumab infusions every 3 weeks; ruxolitinib taken daily
Duration - 1 year
After treatment ends, participants are monitored for side effects and their condition is followed for one year. If side effects occur, the study doctor will follow up until they resolve or stabilize.
Visit schedule depends on side effect monitoring and condition follow-up
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Nurse Navigator
S
Seda Tolu, MD
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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