Last reviewed · How we verify
NCT04548700
Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL
Phase 1 trial testing Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone in Treatment-naïve in 38 participants. Terminated before completion.
30 June 2023
Quick facts
| Lead sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 24 December 2020 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 November 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
- Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
Conditions studied
- Treatment-naïve — all drugs for Treatment-naïve →
- Peripheral T Cell Lymphoma — all drugs for Peripheral T Cell Lymphoma →
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Treatment-naïve or Peripheral T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with peripheral T cell lymphoma (PTCL).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nanoparticles in the clinic: An update post COVID-19 vaccines.
Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246 -
[Chinese expert consensus on the diagnosis and management of nodal peripheral T-cell lymphoma (2025)].
Lymphoma Expert Committee of Chinese Society of Clinical Oncology (CSCO), Lymphoid Disease Group, Chinese Society of Hematology, Chinese Medical Association. · · 2025 · PMID 41486653 · DOI 10.3760/cma.j.cn121090-20250808-00364
Verify or expand the search:
- PubMed search for NCT04548700
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other CSPC ZhongQi Pharmaceutical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT07532655 — A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants · Phase 1 · not yet recruiting
- NCT07412353 — A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085 · Phase 1 · recruiting
- NCT07282509 — Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of · Phase 1, PHASE2 · not yet recruiting
- NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
- NCT07241936 — A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors · Phase 1, PHASE2 · 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 NCT04548700 (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 CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Last refreshed: 7 March 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/NCT04548700.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing