Amping up With PemJAK

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-95
SponsorSeda S. Tolu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: RuxolitinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response (CR) rate

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

Time frame
24 months from the start of study treatment
2

Overall response rate (ORR)

For Arm 2, in patients with Cutaneous T-cell Lymphoma (CTCL), the primary objective will be overall response rate (ORR)

Time frame
24 months from the start of study treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seda S. Tolu

Lead sponsor

Columbia University

Sponsor institution

Incyte Corporation

Collaborator