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

NCT07032532 | Not Yet Recruiting Phase 2

• 1 other identifier: DZ2024J0002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year Progression-Free Survival Rate

  Approximately 3.5 years

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Incidence of adverse events

  Approximately 3.5 years

Study Arms (1)

Golidocitinib monotherapy or Golidocitinib in combination with CHOP

EXPERIMENTAL

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; Drug: Golidocitinib plus CHOP

Interventions

Golidocitinib DRUG

Golidocitinib 150mg orally once daily in a 21-day cycle

Golidocitinib monotherapy or Golidocitinib in combination with CHOP

Golidocitinib plus CHOP DRUG

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.

Golidocitinib monotherapy or Golidocitinib in combination with CHOP

Eligibility Criteria

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

You may qualify if:

• Male and female ≥ 18 years old.
• ECOG performance status 0-2 with no deterioration over the previous 2 weeks.
• Predicted life expectancy ≥ 12 weeks.
• 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
• Patients must have measurable disease according to the 2014 Lugano classification.
• Patients must be treatment naïve with no prior systemic treatment for T-cell lymphoma.
• Adequate bone marrow reserve and organ system functions.
• Willing to comply with contraceptive restrictions.

You may not qualify if:

• 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.
• Major surgery procedure, or significant traumatic injury within 4 weeks.
• Prior treatment with a JAK or STAT3 inhibitor.
• Prior treatment with any onco-immunotherapy in 28 days.
• Live vaccines within 28 days.
• 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.
• Central nervous system or leptomeningeal lymphoma.
• 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.
• Patients with disease condition which requires the treatment of immunosuppressants, biologics, or NSAID.
• Active infections
• Clinically significant cardiac disorders or abnormalities. Acute thrombotic diseases within 90 days.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Huiqiang Huang

CONTACT

020-87343350; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)