Vinorelbine for Recurrent ALCL-2017
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|ClinicalTrials.gov Identifier: NCT03443128|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Large Cell Lymphoma Vinorelbine||Drug: Vinorelbine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||September 2025|
Experimental: Vinorelbine monotherapy treatment
Patients will be treated with Vinorelbine. Four weeks as a course. There are 20 courses in total.
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 [ Time Frame: 4 weeks ]The progression rate will be obtained from the results of simple assessment after one course.
- CR/CRu Rate [ Time Frame: 8 weeks ]The CR/CRu rate will be obtained from the results of simple assessment, CT and FDG-PET after two courses.
- Progression-free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]Compared with historical data.
- Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0. [ Time Frame: 2 years ]The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443128
|Contact: Yijin Gao, MD||86-21-38626161 ext firstname.lastname@example.org|
|Contact: Xingwei Wang, MDemail@example.com|
|Principal Investigator:||Yijin Gao, MD||Shanghai Children's Medical Center|