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
Study ID
NCT05620862
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Pediatric Solid Tumor

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone Hydrochloride Liposome — DRUG
    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)
  • Irinotecan — DRUG
    50mg/ m2，d1-5, 21 days per cycle
  • Vincristine — DRUG
    Vincristine 1.5mg/ m2，d1 , 21 days per cycle

Study Details

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 Dates

Start date
Oct 25, 2022
Status verified
Jul 2024
Primary completion
Sep 1, 2024
Completion
Jun 1, 2025

Study Design

Enrollment
68 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mitoxantrone hydrochloride liposome alone or combined with Irinotecan+Vincristine
    In phase Ia, patients with relapsed and refractory lymphoma and solid tumors will receive mitoxantrone hydrochloride liposome alone (at three doses of 16 mg/m2, 20 mg/m2 and 24 mg/m2, ) or combination of Irinotecan 50mg/ m2，d1-5, Vincristine 1.5mg/ m2，d1 for up to 6 cycles (21 days per cycle). In phase Ib, patients will recive mitoxantrone hydrochloride liposome 24 mg/m2, combination of Irinotecan 50mg/ m2，d1-5, Vincristine 1.5mg/ m2

Primary Outcome Measure

Maximum-tolerated dose [ Time Frame: Up to 21 days ]

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