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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
250mg, BID, PO
50mg, QD, PO, d1-10,21days for one cycle
Auto-HSCT will be performed with patients who have achieved CR or VGPR.
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGORR
Objective Responder Rate
Time frame: up to 24 months
PFS
Progression Free Survival
Time frame: up to 24 months
OS
Overall Survival
Time frame: up to 24 months
adverse events
Number of patients with adverse events
Time frame: up to 24 months
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