Amping up With PemJAK

NCT07283822 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAV7563
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Complete Response (CR) rate

  For Arm 1, in patients with Peripheral T-cell Lymphoma (PTCL), the primary objective will be complete response (CR) rate.

  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)

  24 months from the start of study treatment

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

Ruxolitinib 20mg PO twice daily will be continued until 12 months, disease progression, or development of intolerable side effects (whichever occurs first).

Drug: Ruxolitinib; Drug: Pembrolizumab

Interventions

Ruxolitinib DRUG

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.

Ruxolitinib

Pembrolizumab DRUG

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.

Ruxolitinib

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• \) Diagnosis of Adult T-Cell Leukemia/Lymphoma (ATLL)
• \) History of autoimmune disease that requires systemic treatment.
• \) Has a diagnosis of immunodeficiency or receiving immunosuppressive therapy within 7 days prior to the first dose of study drug.
• \) 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.
• \) 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.
• \) Allowed to have disease progression after or refractory to autologous bone marrow transplant.
• \) Progression after allogeneic stem cell transplantation (SCT) can be determined on a case-by-case basis after discussion with the primary investigator.
• \) History of solid organ transplant requiring active immunosuppression for which treatment with immunotherapy would be contraindicated.
• \) Active TB (Tuberculosis Bacillus) at time screening. Prior cases of adequately treated TB are permissible.
• \) Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
• \) Has severe hypersensitivity (≥ Grade 3) to ruxolitinib and/or any of its excipients.
• Patients with G1 and G2 hypersensitivity remain eligible.
• \) Inability to swallow or take medications by mouth

Sponsors & Collaborators

• Seda S. Tolu: lead
• Incyte Corporation: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous

Interventions

ruxolitinib; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Study Officials

• Seda Tolu, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

(212) 342 5162; cancerclinicaltrials@cumc.columbia.edu

Seda Tolu, MD

CONTACT

212-305-8923; st3406@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 16, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)