Nodal T-follicular Helper Cell LymphomaPhase 2NCT07753642
Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
A Phase 2 study testing Golidocitinib, Doxorubicin and Epirubicin in people with Nodal T-follicular Helper Cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nodal T-follicular Helper Cell Lymphoma
- What is being tested?
- Golidocitinib, Doxorubicin and Epirubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Aug 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.
- Previously untreated with systemic anti-lymphoma therapy.
- Age ≥18 and <75 years.
- At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
- An expected survival time of more than 12 weeks.
- An ECOG performance status score of 0-1.
- Adequate organ and bone marrow function.
- Provision of written informed consent and willingness to comply with all study procedures.
Who cannot join
- Hemophagocytic syndrome.
- Central nervous system or meningeal involvement by lymphoma.
- Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.
- Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.
- Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.
- Patients with severe or uncontrolled cardiovascular disease.
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- Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.
- Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.
- Patients with known hypersensitivity to golidocitinib or its excipients.
- Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.
- Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.
- Patients considered unsuitable for participation by the investigator.
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 Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 51000
Qingqing Cai, MD. PhD., 02087342823, caiqq@sysucc.org.cn
About this study
Official title: A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma
This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.
- Conditions
- Nodal T-follicular Helper Cell Lymphoma
- Being tested
- Golidocitinib, Doxorubicin, Epirubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolidocitinibDrug
150mg, po, qd
DoxorubicinDrug
50 mg/m² intravenously on Day 1 of each 21-day cycle
EpirubicinDrug
60-90 mg/m² intravenously on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib Combined with Doxorubicin/Epirubicin | Experimental | Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator. Receives: Drug: Golidocitinib; Drug: Doxorubicin; Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Defined as the proportion of patients who achieve complete remission at the end of induction treatment.
Measured: Up to 6 cycles (each cycle is 21 days)
Secondary outcomes (5)
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy.
Measured: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Objective response rate (ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR)
Measured: Up to 6 cycles (each cycle is 21 days)
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Measured: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months
Adverse events
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Measured: Up to 28 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodal T-follicular Helper 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
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753642
- Sponsor's protocol ID
- B2026-455
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07753642
- Acronym / sponsor ID
- B2026-455
- Conditions
- Nodal T-follicular Helper Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 7 Aug 2026 (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 is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib Combined with Doxorubicin/Epirubicin | Experimental | Drug: Golidocitinib, Drug: Doxorubicin, Drug: EpirubicinParticipants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.
- Previously untreated with systemic anti-lymphoma therapy.
- Age ≥18 and <75 years.
- At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
- An expected survival time of more than 12 weeks.
Key exclusion criteria (12 listed)
- Hemophagocytic syndrome.
- Central nervous system or meningeal involvement by lymphoma.
- Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.
- Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.
- Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.
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 |
|---|---|---|
| Golidocitinib150mg, po, qd | Drug | Golidocitinib Combined with Doxorubicin/Epirubicin |
| Doxorubicin50 mg/m² intravenously on Day 1 of each 21-day cycle | Drug | Golidocitinib Combined with Doxorubicin/Epirubicin |
| Epirubicin60-90 mg/m² intravenously on Day 1 of each 21-day cycle | Drug | Golidocitinib Combined with Doxorubicin/Epirubicin |
Primary outcome
Complete response rate
Time frame: Up to 6 cycles (each cycle is 21 days)
Defined as the proportion of patients who achieve complete remission at the end of induction treatment.
5 secondary outcomes
Progression-free survival(PFS)
Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival(OS)
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Objective response rate (ORR)
Time frame: Up to 6 cycles (each cycle is 21 days)
Duration of Response(DOR)
Time frame: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months
Adverse events
Time frame: Up to 28 days after the last dose of study treatment
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 7 Aug 2026.
- 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, Doxorubicin and Epirubicin in people with Nodal T-follicular Helper 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 8 inclusion and 12 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 7 Aug 2026. 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 Qingqing Cai, MD. PhD. (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: Up to 6 cycles (each cycle is 21 days)). 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 7 Aug 2026.