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NCT06211881
Chi-GVM Regimen for the Treatment of R/R PTCL
NA trial testing Chi-GVM in Relapsed/Refractory Peripheral T-cell Lymphoma in 50 participants. Status unknown.
30 September 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 25 October 2023 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Chi-GVM — full drug profile →
Conditions studied
- Relapsed/Refractory Peripheral T-cell Lymphoma — all drugs for Relapsed/Refractory Peripheral T-cell Lymphoma →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
Adults 18 to 75, any sex, with Relapsed/Refractory Peripheral T-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). PTCLs have a worse prognosis than aggressive B-cell lymphomas; they are less responsive to standard anthracycline-based chemotherapy regimens and responses are less durable. In an analysis of 341 patients with newly diagnosed PTCL who received anthracycline chemotherapy, 3-year PFS and OS rates were 32% and 52%, respectively, significantly inferior to matched patients with diffuse large B-cell lymphoma (DLBCL).And patients who received consolidative hematopoietic cell transplantation (HCT) had no significant benefit. The prognosis of relapsed/refractory (R/R) patients is even worse. Among the 420 evaluable R/R PTCL patients in the COMPLETE registration study, the median OS of R/R patients were 29 months and 12 months respectively . There is still no effective second-line regimen that can improve patient survival, so treatment options urgently need to be optimized.We designed a randomized, prospective, multi-center phase II clinical trial to explore the efficacy of chidamide combined with gemcitabine, vinorelbine and Mitoxantrone Hydrochloride Liposome (Chi-GVM) in the treatment of patients with R/R PTCL. We expected to further improve ORR, PFS and OS.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06211881
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Related trials
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Currently open trials in the same condition.
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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 NCT06211881 (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 The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 18 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/NCT06211881.
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