Actively Recruiting
Amping up With PemJAK
Led by Seda S. Tolu · Updated on 2025-12-16
53
Participants Needed
1
Research Sites
160 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
The purpose of this study is to understand and determine if ruxolitinib added to pembrolizumab is safe and effective for the treatment of relapsed or refractory Hodgkin and non-Hodgkin lymphomas.
CONDITIONS
Official 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 lymphoma, including specific subtypes listed in the protocol
- Received at least one prior systemic therapy; prior CD30-directed therapy required for systemic ALCL and other CD30-expressing PTCL subtypes
- No chemotherapy or immunotherapy within 2 weeks before study start, with recovery from side effects
- Anti PD-1/PDL-1 therapy allowed up to 2 weeks before enrollment
- Age 18 years or older
- Measurable disease confirmed by PET-CT within 4 weeks or contrast-enhanced CT/MRI
- No active central nervous system disease; treated asymptomatic CNS disease allowed
- Screening for hepatitis B virus with viral load and serologies within 30 days prior to enrollment; prophylaxis required if positive
- History of hepatitis C infection must be treated and cured; undetectable viral load if on treatment
- Known HIV infection allowed if on effective anti-retroviral therapy with undetectable viral load within 26 weeks
- Adequate organ function and performance status (ECOG 0-2 or Karnofsky ≥50)
- Ability to understand and willing to sign informed consent
- History of treated or anticoagulated deep vein thrombosis allowed
- Women of childbearing potential must have negative pregnancy test within 2 weeks before treatment and agree to contraception; men must agree to contraception
- Women must agree not to breastfeed during the study period
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 study dose
- Active chronic systemic steroid therapy exceeding 10 mg prednisone daily or equivalent
- Hodgkin lymphoma and Primary Mediastinal B-cell Lymphoma patients eligible for and agreeable to autologous stem cell transplant; PMBCL patients eligible for and agreeable to CAR-T
- Disease progression after or refractory to autologous bone marrow transplant
- Progression after allogeneic stem cell transplant unless approved by primary investigator
- History of solid organ transplant requiring active immunosuppression contraindicating immunotherapy
- Active tuberculosis at screening; treated TB allowed
- Severe hypersensitivity (≥ Grade 3) to pembrolizumab or ruxolitinib or their excipients
- Inability to swallow or take oral medications
- Pregnant or breastfeeding women or those planning to conceive during study and 120 days after last dose
- Active concurrent malignancy requiring therapy
- Major adverse cardiac events within 6 months prior to enrollment
- Active, systemic, uncontrolled infections at screening except certain treated or localized infections as specified in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Seda Tolu, MD
CONTACT
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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