Vinorelbine for Recurrent ACLC

Sponsor
Children's Cancer Group, China
Study ID
NCT03397953
Phase
PHASE2
Status
Completed

Conditions

  • Anaplastic Large Cell Lymphoma
  • Vinorelbine

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine will be used 25mg/m2/week, rest for 1 week after 3 weeks of continuous use, 4 weeks will be a course. After 1 week there will be a simple assessment, after 2 weeks will be a comprehensive assessment. If the patient got disease progression or partial response/stable disease, he/she would be removed from this trial.

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Jul 2022
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vinorelbine monotherapy treatment
    Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.

Primary Outcome Measure

Event free survival [ Time Frame: 5 years ]

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