Menu
Not yet recruiting NCT07032532

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

Phase II Interventional Peripheral T Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Golidocitinib, Golidocitinib plus CHOP.
Who it may be relevant to
Registry conditions: Peripheral T Cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 2-year Progression-Free Survival Rate [Time frame: Approximately 3.5 years]
Secondary outcome measures (6)
  • Objective Response Rate (ORR) [Time frame: Approximately 3.5 years]
  • Complete Response Rate (CRR) [Time frame: Approximately 3.5 years]
  • Duration of response (DoR) [Time frame: Approximately 3.5 years]
  • Progression-Free Survival (PFS) [Time frame: Approximately 3.5 years]
  • Time To Response (TTR) [Time frame: Approximately 3.5 years]
  • Overall Survival (OS) [Time frame: Approximately 3.5 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Gastrointestinal disorders that is inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of golidocitinib.
  • History of hypersensitivity to active or inactive excipients of golidocitinib or drugs with a similar chemical structure or class.
  • Women who are breast feeding or pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guanzhou

Identifiers

NCT: NCT07032532 · DZ2024J0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗