Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL
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|ClinicalTrials.gov Identifier: NCT03707847|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|ALK-Positive Anaplastic Large Cell Lymphoma||Drug: Crizotinib Drug: Etoposide Capsule Procedure: Auto-HSCT||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-arm, Multi-center Clinical Study of Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory Anaplastic Lymphoma Kinase (ALK)-Positive Anaplastic Large Cell Lymphoma (ALCL)|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: Crizotinib + etoposide capsule+Auto-HSCT
Crizotinib and etoposide capsule followed by autologous hematopoietic stem cell transplantation.
Crizotinib: 250mg, bis in die （BID）, PO.
Etoposide capsule:50mg, quaque die （QD）, PO, d1-10，21days for one cycle.
Patients will receive the treatment of crizotinib and etoposide capsule, and those who have achieved CR（complete response）or VGPR（very good partial response）will undergo the Auto-HSCT.
250mg, BID, PO
Drug: Etoposide Capsule
50mg, QD, PO, d1-10，21days for one cycle
Auto-HSCT will be performed with patients who have achieved CR or VGPR.
- ORR [ Time Frame: up to 24 months ]Objective Responder Rate
- PFS [ Time Frame: up to 24 months ]Progression Free Survival
- OS [ Time Frame: up to 24 months ]Overall Survival
- adverse events [ Time Frame: up to 24 months ]Number of patients with adverse events
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): NCT03707847
|Contact: Mingzhi zhang, Pro,Dr||13838565629||Mingzhi_zhang@126.com|
|Oncology Department of The First Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Mingzhi Zhang, Pro,Dr 13838565629 firstname.lastname@example.org|
|Principal Investigator:||Mingzhi zhang||The First Affiliated Hospital of Zhengzhou University|