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

ALK-Positive Anaplastic Large Cell Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03707847
• Other study ID #: hnslblzlzx20180821
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2018
• Source: Zhengzhou University
• Contact: Mingzhi zhang, Pro,Dr
• Phone: 13838565629
• Email: Mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Criteria: Inclusion Criteria:

• age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score=3;expected survival=3 months

• patients with ALK-positive Anaplastic Large Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);

• Refractory or relapse after at least 4 cycles of CHOP(cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone)regimen

• acceptable hematological indicators, no chemotherapy contraindications;

• total bilirubin = 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) = 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group;

• At least one measurable lesion by CT or PET-CT(Positron Emission Tomography-Computed Tomography);

• exclude other major diseases, normal heart and lung function;

• Female patients of childbearing age are negative for pregnancy test;

• Cooperate with follow-up;

• There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms);

• Signing informed consent *: Pathological histology must be consulted by a pathologist at a provincial hospital.

Exclusion Criteria:

• rejecting providing blood preparation;

• allergic to drug in this study and with metabolic block;

• rejecting adopting reliable contraceptive method in pregnancy or lactation period;

• uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas);

• with severe infection;

• with primary or secondary central nervous system tumor invasion;

• with immunotherapy or radiotherapy contraindication;

• ever suffered with malignant tumor;

• having peripheral nervous system disorder or dysphrenia;

• with no legal capacity,medical or ethical reasons affecting research proceeding;

• participating other clinical trials simultaneously;

• adopting other anti-tumor medicine excluding this research;

• Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients

• Human immunodeficiency virus (HIV)-positive patients

• the researchers considering it inappropriate to participate in the study.

Related Conditions & MeSH terms

• ALK-Positive Anaplastic Large Cell Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Crizotinib
250mg, BID, PO
• 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.

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Responder Rate	up to 24 months
Primary	PFS	Progression Free Survival	up to 24 months
Secondary	OS	Overall Survival	up to 24 months
Secondary	adverse events	Number of patients with adverse events	up to 24 months