NCT05620862

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase I dose escalation and pharmacokinetics clinical trial to evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors. In the phase Ia dose escalation study, patients with relapsed and refractory lymphoma and solid tumors will be treated with mitoxantrone hydrochloride liposome alone or combined treatment at the dose of 16 mg/m2, 20 mg/m2 and 24 mg/m2, each cohort wil enroll 9\~18 children. Simultaneously 6\~15 cases were added for pharmacokinetic study to ensure 8 cases are included in each dose group with the same mitoxantrone hydrochloride liposome dose. In phase Ib, patients received the combination therapy of mitoxantrone hydrochloride liposome at the MTD dose (24mg/m2) .

Conditions

• Pediatric Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-25
• Primary completion: 2024-09-01
• Completion: 2025-06-01
• First posted: 2022-11-17
• Last updated: 2024-07-09

Locations

1 site across 1 country: China