Trials / Unknown

UnknownNCT03707847

Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL

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
Phase: Phase 4
Study type: Interventional
Enrollment: 20 (estimated)

Sponsor: Mingzhi Zhang · Academic / Other
Sex: All
Age: 14 Years – 65 Years
Healthy volunteers: Not accepted

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 survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.

Conditions

ALK-Positive Anaplastic Large Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Crizotinib	250mg, BID, PO
DRUG	Etoposide Capsule	50mg, QD, PO, d1-10，21days for one cycle
PROCEDURE	Auto-HSCT	Auto-HSCT will be performed with patients who have achieved CR or VGPR.

Timeline

Start date: 2018-10-01
Primary completion: 2020-02-01
Completion: 2021-02-01
First posted: 2018-10-16
Last updated: 2018-10-16

Locations

1 site across 1 country: China

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03707847. Inclusion in this directory is not an endorsement.