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NCT07414758: T-START-M1
Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy
Phase 3 trial testing golidocitinib in Peripheral T Cell Lymphoma in 68 participants. Currently enrolling.
30 September 2028
Quick facts
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 15 February 2026 |
| Primary completion | 30 September 2028 |
| Estimated completion | 30 September 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- golidocitinib — full drug profile →
- Placebo
Conditions studied
- Peripheral T Cell Lymphoma — all drugs for Peripheral T Cell Lymphoma →
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
18 and older, any sex, with Peripheral T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation. The investigational intervention consisted of either golidocitinib or matching placebo capsules, administered orally at a planned dose of 150 mg once every other day. Treatment continued until disease progression, initiation of new anti-lymphoma therapy, withdrawal of informed consent, death, or investigator decision to discontinue the study, whichever occurred first. The study treatment period was divided into 28-day cycles starting from the first dose. Efficacy and safety assessments were performed at specified time points within each cycle. The maximum duration of treatment was 2 years. A total of 136 patients were enrolled, with 68 patients assigned to the golidocitinib treatment group and 68 to the placebo control group. Data on demographics and medical history were collected, and assessments including vital signs, physical examination, and PET-CT were conducted.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07414758
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of golidocitinib
Trials testing the same drug.
- NCT07525466 — Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatm · Phase 1, PHASE2 · recruiting
- NCT07300514 — Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma · Phase 3 · recruiting
- NCT07369739 — Golidocitinib Combined With Selinexor for CAEBVD · Phase 2, PHASE3 · recruiting
- NCT07279584 — Golidocitinib Combined With GemOx in RR PTCL · Phase 2 · not yet recruiting
- NCT06966154 — A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Se · Phase 1, PHASE2 · recruiting
Other recruiting trials for Peripheral T Cell Lymphoma
Currently open trials in the same condition.
- NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
- NCT07389616 — A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell · Phase 2, PHASE3 · recruiting
- NCT07353840 — T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR · recruiting
- NCT07253129 — Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort · recruiting
- NCT07470996 — T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR · recruiting
Other Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
- NCT06667466 — New Laser and Suction Sheath for Kidney Stone Treatment · not yet recruiting
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- NCT07415226 — Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes · not yet recruiting
- NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML · Phase 3 · not yet recruiting
- NCT07439120 — Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07414758 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 24 February 2026
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing