Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 25, 2022

Primary Completion Date

September 1, 2024

Study Completion Date

June 1, 2025

Conditions
Pediatric Solid Tumor
Interventions
DRUG

Mitoxantrone Hydrochloride Liposome

In phase Ia, mitoxantrone hydrochloride liposome will be administered by an intravenous infusion at three doses of 16 mg/m2, 20 mg/m2 and 24 mg/m2 . In phase Ib, mitoxantrone hydrochloride liposome will be administered by an intravenous infusion of 24mg/m2. Up to 6 cycles (21 days per cycle)

DRUG

Irinotecan

50mg/ m2,d1-5, 21 days per cycle

DRUG

Vincristine

Vincristine 1.5mg/ m2,d1 , 21 days per cycle

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guangzhou

Sponsors
All Listed Sponsors
collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

lead

Sun Yat-sen University

OTHER

NCT05620862 - Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors | Biotech Hunter | Biotech Hunter