Vinorelbine for Recurrent ALCL-2017

Sponsor
Children's Cancer Group, China
Study ID
NCT03443128
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
    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.

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
Feb 2025
Primary completion
Dec 31, 2024
Completion
Feb 28, 2025

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 with Vinorelbine. Four weeks as a course. There are 20 courses in total.

Primary Outcome Measure

Progression Rate [ Time Frame: 4 weeks ]

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