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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Shanghai Children's Medical Center||Recruiting|
|Shanghai, Shanghai, China, 200127|
|Contact: Yi-Jin Gao, MD 0086-21-38626161 firstname.lastname@example.org|
|Contact: Xing-Wei Wang, MD 0086-21-38626161 email@example.com|
|Principal Investigator:||Yijin Gao, MD||Shanghai Children's Medical Center|