Amping up With PemJAK

Recruiting now · Phase 2

Conditions studied: Non-Hodgkin Lymphoma, Hodgkin Disease Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed, Hodgkin Disease Recurrent, Gray Zone Lymphoma, Peripheral T-cell Lymphoma, Cutaneous T-Cell Lymphomas, Primary Mediastinal B Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT07283822
Run by: Seda S. Tolu
People needed: 53
Starts: 2025-12-03
Expected to finish: 2029-01-01
Last updated by the study team: 2025-12-16

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

(1) Histologically confirmed relapsed/refractory HL, PMBCL, GZL, and TCL including the below subtypes:
Arm 1: PTCL
Nodal PTCL Peripheral T-cell Lymphoma- Not Otherwise Specified (PTCL-NOS)
Anaplastic Large Cell Lymphoma (ALCL) T-follicular Helper Lymphomas (TFH) and its subtypes including angioimmunoblastic T-cell Lymphoma (AITL)
Extranodal NK/T-cell lymphoma
Subcutaneous Panniculitis T-Cell Lymphoma
Arm 2: CTCL
Mycosis Fungoides
Sezary Syndrome
Arm 3: exploratory cohort
Classic HL
PMBCL
GZL
(2) All patients must have received at least one-line systemic therapy.
Patients with systemic ALCL must have received prior CD30-directed therapy.
Other PTCL subtypes that express CD30 (>10%), must have received prior CD30-directed therapy.
Special Consideration for CTCL in Arm 2:
Systemic therapies including bexarotene (targretin) are permissible up to 2 weeks prior to enrollment.
Skin directed therapies including light therapy/phototherapy, extracorporeal photopheresis (ECP), topical steroids, or mechlorethamine (valchlor) gel are NOT considered a systemic line of therapy when given alone.
Treatment with radiation, phototherapy, histone deacetylase inhibitor, retinoids, interferons, therapeutic doses of systemic corticosteroids, or denileukin diftitox (18 µg/kg/day) up to 2 weeks prior to enrollment is allowed.
Treatment with alemutuzumab up to 8 weeks prior to enrollment is permissible.
(3) Patients must not have had chemotherapy or immunotherapy within 2 weeks prior to entering the study and must have recovered from adverse events (to grade 1 or less)
(4) Anti PD-1/PDL-1is permissible up to two weeks prior to enrollment.
(5) Age ≥ 18
(6) Participants must have measurable disease, as defined in the protocol

You may not qualify if…

1) Diagnosis of Adult T-Cell Leukemia/Lymphoma (ATLL)
2) History of autoimmune disease that requires systemic treatment.
3) Has a diagnosis of immunodeficiency or receiving immunosuppressive therapy within 7 days prior to the first dose of study drug.
4) Actively chronic systemic steroids therapy (in dosing exceeding 10mg daily of prednisone or its drug equivalent).
o Patients must be off steroid therapy exceeding 10mg or greater of prednisone (or its equivalent) at the start of therapy.
5) Patients with HL and PMBCL patients must not be eligible and agreeable to autologous stem cell transplant.
o Patients with PMBCL must not be eligible and agreeable to CAR-T.
6) Allowed to have disease progression after or refractory to autologous bone marrow transplant.
7) Progression after allogeneic stem cell transplantation (SCT) can be determined on a case-by-case basis after discussion with the primary investigator.
8) History of solid organ transplant requiring active immunosuppression for which treatment with immunotherapy would be contraindicated.
9) Active TB (Tuberculosis Bacillus) at time screening. Prior cases of adequately treated TB are permissible.
10) Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
11) Has severe hypersensitivity (≥ Grade 3) to ruxolitinib and/or any of its excipients.
Patients with G1 and G2 hypersensitivity remain eligible.
12) Inability to swallow or take medications by mouth
13) Is pregnant or breastfeeding or expected to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
14) History of concurrent and active malignancy for which he or she is currently receiving directed therapy for.
15) History of major adverse cardiac events such as myocardial infraction or stroke within 6 months of enrollment. Cardiovascular events within 6 months such as pulmonary embolism and deep vein thrombosis is permissible if on therapeutic treatment.
16) Subjects with active, systemic, and uncontrolled bacterial, viral, or fungal infections at the time of screening will be excluded from study participation.
Exceptions include:
Infections that have been appropriately treated, with evidence of clinical resolution and return to baseline organ function within 14 days prior to study entry.
Localized, non-systemic infections (e.g., uncomplicated urinary tract infections or cellulitis) that are being actively managed and are not associated with systemic symptoms.
Please see section protocol for eligibility requirements specifically for HCV, HBV, HIV and Tuberculosis infections at time of screening.

Where it is running

Columbia University Irving Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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