NCT07283822

Amping up With PemJAK

A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed/Refractory T-cell Lymphoma and 9p Amplified Lymphomas

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Seda S. Tolu · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

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
• Cutaneous T-Cell Lymphomas
• Primary Mediastinal B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ruxolitinib	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.
DRUG	Pembrolizumab	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.

Timeline

• Start date: 2025-12-03
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study