A Phase 2 interventional study of Vinorelbine in Anaplastic Large Cell Lymphoma and Vinorelbine, sponsored by Children's Cancer Group, China. Completed at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Children's Cancer Group, China · Phase 2, Interventional, and Treatment
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.
Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.
397 studies on the registry are indexed under Lymphoma, Large-Cell, Anaplastic; 26 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 306 interventional studies indexed under Lymphoma, Large-Cell, Anaplastic.
Browse Lymphoma, Large-Cell, Anaplastic studies →Children's Cancer Group, China is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include:
Diagnosed as ALCL, already received treatment, but get disease progression; After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis.
Exclusion Criteria:
Patients with other systemic diseases, severe infections or critically illness.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be treated with Vinorelbine. Four weeks as a course. There are 20 courses in total.
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.
Progression Rate
The progression rate will be obtained from the results of simple assessment after one course.
Time frame: 4 weeks
CR/CRu Rate
The CR/CRu rate will be obtained from the results of simple assessment, CT and FDG-PET after two courses.
Time frame: 8 weeks
Progression-free Survival
Time frame: 2 years
Overall Survival
Compared with historical data.
Time frame: 2 years
Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.
The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0.
Time frame: 2 years
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vinorelbine
Lymphoma, Large-Cell, Anaplastic →
Children's Cancer Group, China