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ACTIVE NOT RECRUITING
NCT05620862
PHASE1

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Phase I dose escalation clinical trial: to explore the dose limiting toxicity (DLT) of mitoxantrone hydrochloride liposome injection in the treatment of children with relapsed and refractory lymphoma and solid tumors. Pharmacokinetics clinical trial: to observe the pharmacokinetics of mitoxantrone hydrochloride liposomes in children with relapsed and refractory lymphoma and solid tumors. To evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors.

Key Details

Gender

All

Age Range

2 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2022-10-25

Completion Date

2025-06-01

Last Updated

2024-07-09

Healthy Volunteers

No

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China