Vinorelbine for Recurrent ACLC-2017
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03443128|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
|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 2018|
|Estimated Study Completion Date :||September 2020|
Experimental: Vinorelbine monotherapy treatment
Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.
Vinorelbine will be used 25mg/m2/week, rest for 1 week after 3 weeks of continuous use, 4 weeks will be a course. After 1 week there will be a simple assessment, after 2 weeks will be a comprehensive assessment. If the patient got disease progression or partial response/stable disease, he/she would be removed from this trial.
- Event free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- 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 email@example.com|
|Contact: Xingwei Wang, MDfirstname.lastname@example.org|
|Shanghai Children's Medical Center||Recruiting|
|Shanghai, Shanghai, China, 200127|
|Contact: Yi-Jin Gao, MD 0086-21-38626161 email@example.com|
|Contact: Xing-Wei Wang, MD 0086-21-38626161 firstname.lastname@example.org|
|Principal Investigator:||Yijin Gao, MD||Shanghai Children's Medical Center|