New pill may keep rare lymphoma in check after chemo
NCT ID NCT07300514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug golidocitinib can help keep peripheral T-cell lymphoma (a rare blood cancer) from coming back after initial chemotherapy. About 136 adults who had a good response to first treatment but cannot or choose not to have a stem cell transplant will take either the drug or a placebo daily for up to 2 years. The goal is to see if the drug extends the time without cancer progression.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Signed written informed consent prior to any study-specific procedures and willingness to comply with all study requirements. * Age ≥18 years at the time of informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without deterioration within 2 weeks before screening. * Histologically confirmed PTCL according to the 2016 WHO classification, limited to the following subtypes: PTCL-not otherwise specified (excluding primary cutaneous PTCL), ALK-positive anaplastic large cell lymphoma (ALK-ALCL), angioimmunoblastic T-cell lymphoma (AITL), or T-follicular helper phenotype PTCL (FTCL or PTCL-TFH). * Achieved complete response (CR) or partial response (PR) after first-line systemic standard chemotherapy with CHOP, BV-CHP, or CHOP-like regimens, as assessed by Lugano 2014 criteria; patients must be ineligible for HSCT (age \>65 years) or eligible but decline HSCT (age ≤65 years). The interval between completion of first-line therapy and planned first dose in this study must be ≤3 months. * Adequate bone marrow and organ function, including: * Absolute neutrophil count (ANC) ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow is involved by lymphoma), without use of colony-stimulating factors within 7 days before study entry. * Platelet count ≥100×10⁹/L (≥75×10⁹/L if bone marrow is involved by lymphoma), without transfusion or platelet growth factors within 7 days before study entry. * Hemoglobin ≥10 g/dL. * Total bilirubin ≤2× upper limit of normal (ULN). * ALT and AST ≤2.5×ULN. * Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated or measured). * Left ventricular ejection fraction (LVEF) ≥50% on echocardiography. * Willingness and ability to comply with study procedures and follow-up. Exclusion Criteria: * Ann Arbor stage I disease at initial diagnosis. * Prior treatments that could interfere with study therapy, including but not limited to: * Investigational agents or antineoplastic drugs within 30 days before first study dose. * Cytotoxic chemotherapy within 21 days before first study dose. * Systemic corticosteroids at a prednisone-equivalent dose \>10 mg/day within 7 days before first study dose. * Major surgery (excluding vascular access procedures) or severe trauma within 4 weeks before first study dose, or planned surgery during study treatment. * Antineoplastic monoclonal antibodies (including brentuximab vedotin) within 4 weeks before first study dose; radiotherapy within 3 weeks; other toxin- or radioisotope-conjugated antibodies within 10 weeks. * Prior treatment with any JAK or STAT3 inhibitor. * Antitumor immunotherapy (e.g., immune checkpoint inhibitors including PD-1, PD-L1, CTLA-4 antibodies) within 28 days before first study dose. * Live attenuated or viral vector vaccines within 28 days before first study dose. * Current use of vitamin K antagonists, antiplatelet or anticoagulant drugs that cannot be discontinued ≥7 days before first study dose. * Concomitant medications that are strong CYP3A inducers or inhibitors, or BCRP/P-gp substrates with narrow therapeutic index that cannot be stopped ≥7 days before first study dose, as specified in the protocol appendix. * Active hepatitis C infection (positive anti-HCV antibody). * Hepatitis B virus (HBV) DNA ≥1000 IU/mL or other HBV status not meeting protocol-defined criteria for safe inclusion. * Known HIV infection with confirmed positive serology. * Any uncontrolled, clinically significant comorbidities or laboratory abnormalities that, in the investigator's judgment, would increase risk or interfere with study participation. * History of drug-induced interstitial lung disease or current evidence of clinically significant interstitial lung disease. * Pregnant or breastfeeding women; women of childbearing potential and men with fertile partners who are unwilling or unable to use effective contraception during treatment and for the protocol-specified period after the last dose.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Fourth-Generation ALK blocker put to the test against resistant cancers
- Can a powerful combo of drugs and stem cell transplant beat tough lymphomas in kids?
- Can a smart immune cell with a kill switch beat tough lymphomas?
- Engineered donor cells take on lymphoma in early trial
- Promising combo tackles rare blood cancer in chinese patients