CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 115 target
Drug / intervention
CMOEPdrug
Likely dose
CMOEP 18 mgfrom record
Key inclusion· 4
  • Histologically confirmed diagnosis of Peripheral T-cell lymphoma (PTCL-NOS, AITL, ALCL ALK+, ALCL ALK-, or other investigator-approved PTCL subtypes)
  • At least one evaluable or measurable lesion per Lugano 2014 criteria (lymph node >1.5 cm, non-lymph node >1.0 cm)
  • Expected survival ≥3 months
  • Age 18-70 years (65-70 year-olds require comprehensive evaluation of physical fitness and tolerance)
Key exclusion· 8
  • Prior antitumor therapy including chemotherapy, targeted therapy, immunotherapy, or radiotherapy for lymphoma (except local radiotherapy for symptom relief)
  • Hypersensitivity to study drug or components
  • Uncontrolled systemic diseases (active infection, uncontrolled hypertension, diabetes)
  • Active hepatitis B (HBsAg+ and HBV DNA >1×10³ copy/mL) or hepatitis C (HCV RNA >1×10³ copy/mL)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06433362
NCT06433362Phase 2RecruitingUpdate OverdueUpdated 25mo ago · Completion was 12mo ago
Enrollment Stalled
Update Overdue

A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Treatment-Naive Patients With Peripheral T-Cell Lymphoma

Tianjin Medical University Cancer Institute and Hospital·interventional·Posted May 29, 2024·Updated May 29, 2024

In Brief

A Phase 2 clinical trial evaluating CMOEP for Peripheral T Cell Lymphoma. Currently recruiting, targeting 115 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
20252026
First PostedMay 29, 2024
Enrollment StartJun 1, 2024
Primary CompletionJun 30, 2025
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.1 years ago

Interventions

CMOEPdrug

Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 3 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1,every 3 weeks; Drug: Vincristine Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 3 mg/m2, the maximum dose of 4mg),every 3 weeks; Drug: Etoposide Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3,every 3 weeks;