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

NCT05620862 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-07-09

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2024-09-01
Completion
2025-06-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620862 on ClinicalTrials.gov