Clinical Trials Logo
  1. Home
  2. Peripheral T-cell Lymphoma
  3. NCT04548700

Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL

Peripheral T Cell Lymphoma Clinical Trial

Official title:
Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL

Clinical Trial Summary

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).

Clinical Trial Description

The study is to investigate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with PTCL by conducting in two stages, Dose-finding stage and Dose-expansion stage.In Dose-finding stage, patients with treatment-naïve PTCL will be assigned to receive sequentially higher doses of liposomal mitoxantrone hydrochloride ranging from 12 to 18 mg/m2 plus Cyclophosphamide, Vincristine and Prednisone (28 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended Phase 2 dose (RP2D) of liposomal mitoxantrone hydrochloride will be determined according to the Dose-finding results. In Dose-expansion stage, additional patients will be recruited into two groups, the Q4W group（28 days per cycle）and the Q3W group（21 days per cycle）, to receive liposomal mitoxantrone hydrochloride at the RP2D combined with Cyclophosphamide, Vincristine and Prednisone. All patients will receive the treatment for the planned 6 cycles or until disease progression or unacceptable drug-related adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04548700
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Xuefang Xia
Phone 18963980673
Email xiaxuefang@mail.ecspc.com
Status Recruiting
Phase Phase 1
Start date December 24, 2020
Completion date October 15, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT05559008 - A Umbrella Study in R/R PTCL Guided by Molecular Subtypes Phase 1/Phase 2
Not yet recruiting NCT02856997 - Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04083495 - CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma Phase 2
Recruiting NCT04984837 - Study of Lacutamab in Peripheral T-cell Lymphoma Phase 2
Active, not recruiting NCT01716806 - A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) Phase 2
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04028440 - γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Early Phase 1
Active, not recruiting NCT03586999 - Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Phase 1/Phase 2
Recruiting NCT04489264 - The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Recruiting NCT02753543 - Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma Phase 2
Active, not recruiting NCT04101331 - Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides Phase 2
Not yet recruiting NCT04457830 - The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL). Phase 2
Recruiting NCT05290155 - Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies Phase 1
Recruiting NCT04828174 - Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies Phase 1
Withdrawn NCT03999658 - A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies Phase 2
Recruiting NCT02944812 - Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma Phase 2
Recruiting NCT05321147 - Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2 Phase 1
Recruiting NCT03719105 - Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma Early Phase 1
Recruiting NCT03268889 - Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma) N/A