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NCT05675813: THEORY
Genotype-guided Treatment in Newly Diagnosed PTCL
Phase 1, PHASE2 trial testing CHOP+selinexor+5-Azacitidine in Peripheral T Cell Lymphoma in 264 participants. Currently enrolling.
15 July 2026
Quick facts
| Lead sponsor | Ruijin Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 264 |
| Start date | 13 February 2023 |
| Primary completion | 15 July 2026 |
| Estimated completion | 15 July 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- CHOP+selinexor+5-Azacitidine — full drug profile →
- CHOP+duvelisib+5-Azacitidine — full drug profile →
- CHOP+chidamide+tislelizumab — full drug profile →
- standard CHOP — full drug profile →
Conditions studied
- Peripheral T Cell Lymphoma — all drugs for Peripheral T Cell Lymphoma →
Sponsor
Ruijin Hospital
Who can join
Adults 18 to 75, any sex, with Peripheral T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Converting "cold" to "hot": epigenetics strategies to improve immune therapy effect by regulating tumor-associated immune suppressive cells.
Tang Y, Cui G, Liu H, Han Y, et al · · 2024 · cited 28× · PMID 38715348 · DOI 10.1002/cac2.12546 -
Genomic and transcriptomic profiling of peripheral T cell lymphoma reveals distinct molecular and microenvironment subtypes.
Huang YH, Qiu YR, Zhang QL, Cai MC, et al · · 2024 · cited 16× · PMID 38350451 · DOI 10.1016/j.xcrm.2024.101416 -
Targeted agents plus CHOP compared with CHOP as the first-line treatment for newly diagnosed patients with peripheral T-cell lymphoma (GUIDANCE-03): an open-label, multicentre phase 2 clinical trial.
Cai MC, Cheng S, Jing HM, Liu Y, et al · · 2024 · cited 5× · PMID 39175480 · DOI 10.1016/j.lanwpc.2024.101160 -
BV and beyond: how to incorporate novel agents into PTCL management.
Nizamuddin IA, Mehta-Shah N. · · 2024 · cited 2× · PMID 39644004 · DOI 10.1182/hematology.2024000530 -
Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?
Sokolova V, Gruber R, Pammer LM, Kocher F, et al · · 2024 · cited 1× · PMID 39729162 · DOI 10.1007/s11033-024-10169-5
Verify or expand the search:
- PubMed search for NCT05675813
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral T Cell Lymphoma
Currently open trials in the same condition.
- NCT07414758 — Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy · Phase 3 · recruiting
- 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
Other Ruijin Hospital trials
Trials by the same sponsor.
- NCT07589361 — Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors · not yet recruiting
- NCT07449507 — Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy · NA · not yet recruiting
- NCT07496385 — Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound · NA · not yet recruiting
- NCT07511114 — A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyp · Phase 3 · not yet recruiting
- NCT07514169 — The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL · Phase 2 · 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 NCT05675813 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruijin Hospital
- Last refreshed: 8 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05675813.
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