Vinorelbine for Recurrent ALCL-2017

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

December 31, 2024

Study Completion Date

February 28, 2025

Conditions
Anaplastic Large Cell LymphomaVinorelbine
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.

Trial Locations (1)

200127

Shanghai Children's Medical Center, Shanghai

All Listed Sponsors
lead

Children's Cancer Group, China

NETWORK

NCT03443128 - Vinorelbine for Recurrent ALCL-2017 | Biotech Hunter | Biotech Hunter