Non-Hodgkin LymphomaPhase 2NCT07283822
Amping up With PemJAK
A Phase 2 study testing Ruxolitinib and Pembrolizumab in people with Non-Hodgkin Lymphoma and Hodgkin Disease Lymphoma, run by Seda S. Tolu at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Hodgkin Disease Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed
- What is being tested?
- Ruxolitinib and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
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- 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
- Patients must have a PET-CT scan performed within ≤4 weeks.
- Contrast enhanced CT scan or MRI of the neck, chest, abdomen, pelvis is permissible, however; PET is preferred.
- (7) Patients cannot have active central nervous system (CNS) disease. Patients that have been treated and asymptomatic are allowed on study.
- (8) All participants must be screened for chronic hepatitis B virus (HBV) with hepatitis B viral load and serologies (core antibody, surface antigen, and surface antibody) within 30 days prior to enrollment.
- Patients with positive Hep B core will need to be on HBV prophylaxis
- Patients with positive Hep B core will need to be on HBV prophylaxis.
- (9) Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. If actively on treatment, HCV viral load mut be undetectable 30 days prior to enrollment.
- (10) Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to enrollment).
- (11) Organ function as assessed by laboratory testing and Eastern Cooperate Oncology Group (ECOG) performance status 0-2 and or a Karnofsky performance score of equal or greater to 50 (see Section 20.1.1, Appendix A) for receipt of ruxolitinib and pembrolizumab.
- Absolute Neutrophil Count ≥ 1000/μL (not growth factor independent)
- Platelets ≥ 70,000/μL (or ≥50,000/mm3 if known bone marrow involvement with dose modifications allowed. See protocol for specific instructions for dose modifications).
- Baseline hemoglobin level ≥ 8 g/dL (irrespective of bone marrow involvement).
- Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula
- Bilirubin ≤ 2 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN
- (12) Ability to understand and the willingness to sign a written informed consent document.
- (13) Patients with prior history of deep vein thrombosis (DVT) that has been treated or actively requiring anticoagulation are permitted to enroll.
- (14) Due to the potential teratogenic effects, women of childbearing age must have a documented negative serum β-hCG measured within 2 weeks of starting treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician and Incyte immediately (see protocol). Additionally, both women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).
- Contraception should continue for 6 months after you stop taking study drug. Similarly, women must agree to not breastfeed during the entirety of the study period.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Research Nurse Navigator, RN, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Seda Tolu, MD, 212-305-8923, st3406@cumc.columbia.edu
About this study
Official title: A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed/Refractory T-cell Lymphoma and 9p Amplified Lymphomas
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.
Read the detailed description
This study includes peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphomas (CTCL), and other lymphomas (Hodgkin Lymphoma [HL], Gray Zone Lymphomas [GZL], and Primary Mediastinal B-cell Lymphoma [PMBCL]) that has become resistant to commonly available chemotherapy (refractory), or it has re-occurred after treatment (relapsed). For PTCL participants, the main goal is to see how many achieve complete remission (no signs of cancer). For CTCL participants, the focus is on the overall response rate, meaning how many show improvement. This study is also open to patients with Hodgkin Lymphoma (HL), Gray Zone Lymphoma (GZL), and Primary Mediastinal B-cell Lymphoma (PMBCL), to understand if ruxolitinib can work in a disease that shares similar characteristics. It is important to note that ruxolitinib is an investigational drug and is not FDA approved for these lymphomas, but has shown to be effective in combination with immunotherapy in clinical trials. In addition, pembrolizumab is only FDA approved for HL and PMBCL - however is commonly used in PTCL, CTCL, and GZL in the relapsed setting as treatment options are limited and prior trials with pembrolizumab has shown effectiveness in treating these lymphomas.
- Conditions
- Non-Hodgkin Lymphoma, Hodgkin Disease Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed, Hodgkin Disease Recurrent, Gray Zone Lymphoma, Peripheral T-cell Lymphoma
- Being tested
- Ruxolitinib, Pembrolizumab
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Patients will receive the study drug ruxolitinib for as long as the disease responds, for up to a maximum of one year (or 17 cycles). After study treatment with ruxolitinib is finished, the study doctor will continue to watch for side effects and follow the condition for one year. If any side effects are experienced, the study doctor will follow up until resolution or stabilization of the side effect.
PembrolizumabDrug
Pembrolizumab immunotherapy will be administered intravenously at 200 mg once every 21 days. Subjects will receive pembrolizumab for as long as the disease responds, up to a maximum of one year (or 17 cycles). Each cycle is 21 days long.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | Ruxolitinib 20mg PO twice daily will be continued until 12 months, disease progression, or development of intolerable side effects (whichever occurs first). Receives: Drug: Ruxolitinib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) rate
For Arm 1, in patients with Peripheral T-cell Lymphoma (PTCL), the primary objective will be complete response (CR) rate.
Measured: 24 months from the start of study treatment
Overall response rate (ORR)
For Arm 2, in patients with Cutaneous T-cell Lymphoma (CTCL), the primary objective will be overall response rate (ORR)
Measured: 24 months from the start of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start3 Dec 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seda S. Tolu
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor-investigator, Seda S. Tolu, Columbia University
- Investigators
- Seda Tolu, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283822
- Sponsor's protocol ID
- AAAV7563
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed/Refractory T-cell Lymphoma and 9p Amplified Lymphomas
- ClinicalTrials.gov ID
- NCT07283822
- Acronym / sponsor ID
- AAAV7563
- Conditions
- Non-Hodgkin Lymphoma, Hodgkin Disease Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed, Hodgkin Disease Recurrent, Gray Zone Lymphoma, Peripheral T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Seda S. ToluUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study includes peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphomas (CTCL), and other lymphomas (Hodgkin Lymphoma [HL], Gray Zone Lymphomas [GZL], and Primary Mediastinal B-cell Lymphoma [PMBCL]) that has become resistant to commonly available chemotherapy (refractory), or it has re-occurred after treatment (relapsed). For PTCL participants, the main goal is to see how many achieve complete remission (no signs of cancer). For CTCL participants, the focus is on the overall response rate, meaning how many show improvement. This study is also open to patients with Hodgkin Lymphoma (HL), Gray Zone Lymphoma (GZL), and Primary Mediastinal B-cell Lymphoma (PMBCL), to understand if ruxolitinib can work in a disease that shares similar characteristics. It is important to note that ruxolitinib is an investigational drug and is not FDA approved for these lymphomas, but has shown to be effective in combination with immunotherapy in clinical trials. In addition, pembrolizumab is only FDA approved for HL and PMBCL - however is commonly used in PTCL, CTCL, and GZL in the relapsed setting as treatment options are limited and prior trials with pembrolizumab has shown effectiveness in treating these lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: Ruxolitinib, Drug: PembrolizumabRuxolitinib 20mg PO twice daily will be continued until 12 months, disease progression, or development of intolerable side effects (whichever occurs first). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- (1) Histologically confirmed relapsed/refractory HL, PMBCL, GZL, and TCL including the below subtypes:
- (2) All patients must have received at least one-line systemic therapy.
- (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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibPatients will receive the study drug ruxolitinib for as long as the disease responds, for up to a maximum of one year (or 17 cycles). After study treatment with ruxolitinib is finished, the study doctor will continue to watch for side effects and follow the condition for one year. If any side effects are experienced, the study doctor will follow up until resolution or stabilization of the side effect. | Drug | Ruxolitinib |
| PembrolizumabPembrolizumab immunotherapy will be administered intravenously at 200 mg once every 21 days. Subjects will receive pembrolizumab for as long as the disease responds, up to a maximum of one year (or 17 cycles). Each cycle is 21 days long. | Drug | Ruxolitinib |
Primary outcome
Complete Response (CR) rate
Time frame: 24 months from the start of study treatment
For Arm 1, in patients with Peripheral T-cell Lymphoma (PTCL), the primary objective will be complete response (CR) rate.
Overall response rate (ORR)
Time frame: 24 months from the start of study treatment
For Arm 2, in patients with Cutaneous T-cell Lymphoma (CTCL), the primary objective will be overall response rate (ORR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda Tolu, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib and Pembrolizumab in people with Non-Hodgkin Lymphoma and Hodgkin Disease Lymphoma, run by Seda S. Tolu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 45 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Nurse Navigator ((212) 342 5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate (time frame: 24 months from the start of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.