Peripheral T Cell LymphomaPhase 2NCT07032532
Assessing An Oral JAK1 Inhibitor, Golidocitinib, in Patients Who Have Newly Diagnosed Peripheral T-Cell Lymphoma (JACKPOT23)
A Phase 2 study testing Golidocitinib and Golidocitinib plus CHOP in people with Peripheral T Cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Golidocitinib and Golidocitinib plus CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, 510060
Huiqiang Huang, 020-87343350, huanghq@sysucc.org.cn
About this study
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
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
- Being tested
- Golidocitinib, Golidocitinib plus CHOP
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolidocitinibDrug
Golidocitinib 150mg orally once daily in a 21-day cycle
Golidocitinib plus CHOPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Golidocitinib; Drug: Golidocitinib plus CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Progression-Free Survival Rate
Measured: Approximately 3.5 years
Secondary outcomes (6)
Objective Response Rate (ORR)
Measured: Approximately 3.5 years
Complete Response Rate (CRR)
Measured: Approximately 3.5 years
Duration of response (DoR)
Measured: Approximately 3.5 years
Progression-Free Survival (PFS)
Measured: Approximately 3.5 years
Time To Response (TTR)
Measured: Approximately 3.5 years
Overall Survival (OS)
Measured: Approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032532
- Sponsor's protocol ID
- DZ2024J0002
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07032532
- Acronym / sponsor ID
- DZ2024J0002
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib monotherapy or Golidocitinib in combination with CHOP | Experimental | Drug: Golidocitinib, Drug: Golidocitinib plus CHOPDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Patients must have measurable disease according to the 2014 Lugano classification.
Key exclusion criteria (18 listed)
- Intervention with any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolidocitinibGolidocitinib 150mg orally once daily in a 21-day cycle | Drug | Golidocitinib monotherapy or Golidocitinib in combination with CHOP |
| Golidocitinib plus CHOPGolidocitinib 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. | Drug | Golidocitinib monotherapy or Golidocitinib in combination with CHOP |
Primary outcome
2-year Progression-Free Survival Rate
Time frame: Approximately 3.5 years
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golidocitinib and Golidocitinib plus CHOP in people with Peripheral T Cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang (020-87343350, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Progression-Free Survival Rate (time frame: Approximately 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.