New pill aims to stop rare lymphoma from coming back

NCT ID NCT07414758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether the drug golidocitinib can help people with peripheral T-cell lymphoma (PTCL) stay in remission longer after their first round of chemotherapy. About 136 patients who responded to chemo will receive either golidocitinib or a placebo pill every other day for up to 2 years. The main goal is to see if the drug delays disease progression or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
golidocitinib
What this could lead to
If successful, this could provide a new maintenance option to delay lymphoma progression after initial chemotherapy.
What could go wrong
This is a relatively small Phase 3 trial (68 per arm), and the drug may not improve survival or could cause side effects. Results may not apply to all PTCL subtypes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to comply with the requirements and restrictions listed in the ICF and this study protocol. * Age \>18 years at the time of signing the ICF. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, with no deterioration within the last 2 weeks. * Histopathologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al., 2016). Eligible histological subtypes are limited to: PTCL-NOS (excluding primary cutaneous), ALK-negative ALCL, AITL, and follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH). * Subjects must have achieved a Complete Response (CR) or Partial Response (PR) as assessed by the Lugano 2014 criteria following first-line systemic standard therapy (limited to CHOP, BV-CHP, or CHOP-like regimens), and are either transplant-ineligible (age \>65 years) or transplant-eligible (age ≤65 years) but have provided written refusal for transplantation. The time from the end of initial therapy to the planned first dose in this study must be ≤3 months. * Adequate bone marrow and organ function, as defined below: 1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L in case of bone marrow involvement by lymphoma). Subjects must not have used colony-stimulating factors within 7 days prior to study entry. 2. Platelet count ≥100 × 10⁹/L (≥75 × 10⁹/L in case of bone marrow involvement by lymphoma). Subjects must not have received transfusion or thrombopoietic agents within 7 days prior to study entry. 3. Hemoglobin ≥10 g/dL. 4. Total bilirubin ≤2 × Upper Limit of Normal (ULN). 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. 6. Serum creatinine ≤1.5 × ULN, OR calculated or measured creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min, OR a 24-hour urine collection demonstrating a creatinine clearance ≥50 mL/min. * Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiogram (ECHO). * Voluntarily participate in the clinical study; fully understand and are informed about this study and sign the ICF; willing and able to follow and complete all trial procedures. Exclusion Criteria: * Patients with clinical stage Ann Arbor I disease. * Any of the following treatment histories: 1. Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose. 2. Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose. 3. Received systemic corticosteroid therapy at a dose \>10 mg prednisone equivalent per day within 1 week prior to the first study dose. 4. Underwent major surgery (excluding vascular access procedures) or experienced significant trauma within 4 weeks prior to the first study dose, or has planned surgery during the study. 5. Received antitumor monoclonal antibody therapy (including brentuximab vedotin) within 4 weeks; radiotherapy within 3 weeks; or other toxin/radioisotope-immunoconjugate therapy within 10 weeks prior to the first study dose. 6. Prior treatment with a JAK or STAT3 inhibitor. 7. Received antitumor immunotherapy (e.g., immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, anti-CTLA-4) within 28 days prior to the first study dose. 8. Received live-attenuated or viral vector vaccines within 28 days prior to the first study dose. 9. Current use (or inability to discontinue ≥1 week prior to the first dose) of vitamin K antagonists, antiplatelet agents, or anticoagulants. Current use (or inability to discontinue ≥1 week prior to the first dose) of medications, herbal supplements, or foods known to be potent inducers or inhibitors of CYP3A, or sensitive substrates of BCRP/P-gp with a narrow therapeutic index (see Appendix F for guidance on potentially interacting concomitant medications). * History of other active malignancies within the past 5 years, except for curatively treated localized cancers such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. * Active infection, including: 1. Known active or latent tuberculosis, evidenced by a positive PPD skin test (\>10 mm induration, or per local clinical criteria) or findings suggestive of active/latent TB on chest X-ray/CT. 2. Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS). 3. Chronic active Hepatitis B or C infection, except: <!-- --> 1. Subjects positive for HBsAg or HBcAb are eligible if HBV-DNA is undetectable. 2. Subjects positive for HCV antibody are eligible if HCV-RNA is undetectable. (The ULN for HBV-DNA and HCV-RNA assays is defined per each center's laboratory standards.) (d) Other active viral infections (e.g., herpes zoster), cytomegalovirus (CMV), or Epstein-Barr virus (EBV) infection, excluding Hepatitis B and C. Active infection requiring intravenous antimicrobial therapy, characterized by hemodynamic instability, worsening/new infectious symptoms/signs, new infectious foci on imaging, or persistent fever without other explanation. * Poorly controlled or clinically significant cardiac disease, such as: i. Heart failure \> New York Heart Association (NYHA) class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention. * Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception. * History of severe psychiatric disorders or inability to provide informed consent. * Subjects with refractory nausea, vomiting, or chronic gastrointestinal diseases that may impair drug absorption. * Significant impairment of pulmonary function, defined as forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) \<60% of predicted. * Presence of unresolved drug-related toxicities \> Grade 1 per CTCAE (except for alopecia) prior to the first study dose. * Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General hospital,Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

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