Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03707847
Status:
UNKNOWN
Last Update Posted:
2018-10-16
First Post:
2018-09-23
Brief Title:
Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK ALCL
Sponsor:
Mingzhi Zhang
Organization:
Zhengzhou University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To observe the safety tolerability and clinical effects of crizotinib combined with etoposide capsule followed by autologous hematopoietic stem cell transplantation Auto-HSCT for patients with relapsed and refractory ALK-positive Anaplastic Large Cell Lymphoma
Detailed Description:
This is a prospective open-label one-arm multicenter clinical trial aimed to evaluate the safety tolerability and efficacy of crizotinib combined with etoposide followed by autologous hematopoietic stem cell transplantation for relapsed and refractory ALK-positive ALCL A total of 20 patients are planned to be enrolled into the study Patients with diagnosis of relapsed and refractory ALK-positive ALCL will be treated with crizotinib plus etoposide capsules followed by autologous hematopoietic stem cell transplantation The primary end points are objective responder rate ORR and progression free survivalPFS and the secondary end points include overall survivalOS and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None