Assessing An Oral JAK1 Inhibitor, Golidocitinib, in Patients Who Have Newly Diagnosed Peripheral T-Cell Lymphoma (JACKPOT23)

An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Golidocitinib in First-Line Therapy of Peripheral T-Cell Lymphoma

This study will treat patients with newly diagnosed PTCL, who have no prior systemic treatment for T-cell lymphoma. This study will assess the anti-tumor efficacy of golidocitinib using 2-year Progression-Free Survival rate as primary endpoint. In addition, it will help to understand what type of side effects may occur with the drug treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: Golidocitinib; Drug: Golidocitinib plus CHOP

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Huiqiang Huang; Phone Number: 020-87343350; Email: huanghq@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
      • Contact: Huiqiang Huang; Phone Number: 020-87343350; Email: huanghq@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female ≥ 18 years old.
2. ECOG performance status 0-2 with no deterioration over the previous 2 weeks.
3. Predicted life expectancy ≥ 12 weeks.

4. Patients must have histologically confirmed peripheral T-cell lymphoma. Eligible histological subtypes are restricted to the following:

   • PTCL, not otherwise specified (PTCL, NOS) (the proportion of PTCL-NOS subtype will not exceed 30% of all enrolled)
   • Angioimmunoblastic T-cell lymphoma (AITL)
   • Follicular T cell lymphoma
   • PTCL with T follicular helper (TFH) phenotype
5. Patients must have measurable disease according to the 2014 Lugano classification.
6. Patients must be treatment naïve with no prior systemic treatment for T-cell lymphoma.
7. Adequate bone marrow reserve and organ system functions.
8. Willing to comply with contraceptive restrictions.

Exclusion Criteria:

1. Intervention with any of the following:

   • Any investigational anti-cancer agents or study anti-cancer drugs from a previous clinical study.
   • Any cytotoxic chemotherapy from a previous treatment regimen.
   • Corticosteroids at dosages equivalent to prednisone > 40 mg/day within 7 days.
2. Major surgery procedure, or significant traumatic injury within 4 weeks.
3. Prior treatment with a JAK or STAT3 inhibitor.
4. Prior treatment with any onco-immunotherapy in 28 days.
5. Live vaccines within 28 days.
6. Patients currently receiving (or unable to stop use at least 14 days prior to receiving the first dose) medications or herbal supplements known to be Potent inhibitors or inducers of CYP3A.
7. Central nervous system or leptomeningeal lymphoma.
8. Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
9. Patients with disease condition which requires the treatment of immunosuppressants, biologics, or NSAID.
10. Active infections
11. Clinically significant cardiac disorders or abnormalities. Acute thrombotic diseases within 90 days.
12. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
13. Gastrointestinal disorders that is inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of golidocitinib.
14. History of hypersensitivity to active or inactive excipients of golidocitinib or drugs with a similar chemical structure or class.
15. Women who are breast feeding or pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Golidocitinib monotherapy or Golidocitinib in combination with CHOP; During induction therapy, eligible patients will receive golidocitinib 150mg orally once daily for 6 induction cycles and then undergo restaging (PET/CT scan). Patients that achieve CR will continue golidocitinib monotherapy for 6 more cycles at the previously described dose; patients that achieve PR or SD will receive golidocitinib 150 mg every other day in combination with CHOP for 6 cycles. The maintenance therapy starts at Cycle 13 Day 1 and will consist of golidocitinib at 150 mg once daily for up to 1 year in patients that achieve CR, or continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or the study is terminated by the investigator and/or IND sponsor for PR/SD patients . A treatment cycle consists of 21 days.

Drug: Golidocitinib; Golidocitinib 150mg orally once daily in a 21-day cycle; Drug: Golidocitinib plus CHOP; Golidocitinib 150mg orally every other day with CHOP (Cyclophosphamide: 750mg/m2, IV, d1 ; Doxorubicin: 50mg/m2, IV, d1; Vincristine: 1.4mg/m2, IV, d1 ; Prednison: 100mg, po, d1-5) in a 21-day cycle for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year Progression-Free Survival Rate	Approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Approximately 3.5 years
Complete Response Rate (CRR)	Approximately 3.5 years
Duration of response (DoR)	Approximately 3.5 years
Progression-Free Survival (PFS)	Approximately 3.5 years
Time To Response (TTR)	Approximately 3.5 years
Overall Survival (OS)	Approximately 3.5 years

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Approximately 3.5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 19, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: DZ2024J0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No