Last reviewed · How we verify
NCT05527275
A Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma
Phase 1, PHASE2 trial testing Mitoxantrone liposome combine with Chidamide in Relapsed and Refractory Peripheral T-cell Lymphoma in 78 participants. Status unknown.
1 September 2024
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 1 October 2022 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Mitoxantrone liposome combine with Chidamide — full drug profile →
Conditions studied
- Relapsed and Refractory Peripheral T-cell Lymphoma — all drugs for Relapsed and Refractory Peripheral T-cell Lymphoma →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Relapsed and 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 highly heterogeneous group of aggressive non-Hodgkin lymphoma (NHL) originating from mature thymus T cells.Mitoxantrone Hydrochloride Liposome Injection can accelerate the entry of mitoxantrone into cells, reduce the efflux of mitoxantrone, ensure the concentration of intracellular drugs, reverse the drug resistance mechanism, and enhance anti-tumor activity.We will explore the dose-limiting toxicity (DLT) of Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma, estimate the maximum tolerated dose (MTD) of the combination, and determine the phase II recommended dose RP2D.In the phase II study, we will evaluate the safety and efficacy of the combination regimen.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Case report: Good response to CMOP regimen containing mitoxantrone hydrochloride liposome (PLM60) as induction chemotherapy in patients with angioimmunoblastic T-cell lymphoma.
Liang L, Jiang M. · · 2024 · cited 1× · PMID 38357199 · DOI 10.3389/fonc.2024.1331154 -
Publication Only
· 2025
Verify or expand the search:
- PubMed search for NCT05527275
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05527275 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Sun Yat-sen University
- Last refreshed: 2 September 2022
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/NCT05527275.
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