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Vinorelbine for Recurrent ALCL-2017

NCT03443128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-13

No results posted yet for this study

Summary

The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

Conditions

Interventions

DRUG

Vinorelbine

During each course, patients will be treated with vinorelbine (25mg/m2/week on weeks 1-3). After 1 course(4 weeks) of vinorelbine, response will be evaluated by simple assessment: clinical symptoms, signs, B ultrasound, chest X-ray, peripheral blood test and bone marrow smear(if needed). After 2 courses, response will be evaluatedy by simple assessment, CT and FDG-PET. The CR/CRu was defined by anatomic tumour shrinkage more than 75% after 2 courses based on CT with negative PET assessment, with negative bone marrow PCR(if needed) and without CNS involvement. Patients who achieved a CR/CRu after two courses either will proceed to stem cell transplantation (SCT) or will receive additional courses of therapy while awaiting SCT. Response was re-evaluated at the end of every 2 courses. Patients with progressive disease at any time during treatment will be removed from protocol therapy.

Sponsors & Collaborators

  • Children's Cancer Group, China

    lead NETWORK

Principal Investigators

  • Yijin Gao, MD · Shanghai Children's Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2024-12-31
Completion
2025-02-28

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 NCT03443128 on ClinicalTrials.gov