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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
Sponsor:
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

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.

Condition or disease Intervention/treatment Phase
ALK-Positive Anaplastic Large Cell Lymphoma Drug: Crizotinib Drug: Etoposide Capsule Procedure: Auto-HSCT Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. ORR [ Time Frame: up to 24 months ]
    Objective Responder Rate

  2. PFS [ Time Frame: up to 24 months ]
    Progression Free Survival


Secondary Outcome Measures :
  1. OS [ Time Frame: up to 24 months ]
    Overall Survival

  2. adverse events [ Time Frame: up to 24 months ]
    Number of patients with adverse events



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mingzhi zhang, Pro,Dr 13838565629 Mingzhi_zhang@126.com

Locations
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China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    13838565629    mingzhi_zhang@126.com   
Sponsors and Collaborators
Mingzhi Zhang
Investigators
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Principal Investigator: Mingzhi zhang The First Affiliated Hospital of Zhengzhou University

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Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT03707847     History of Changes
Other Study ID Numbers: hnslblzlzx20180821
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mingzhi Zhang, Zhengzhou University:
crizotinib
etoposide
autologous hematopoietic stem cell transplantation
ORR
OS
PFS
adverse events

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Etoposide
Etoposide phosphate
Crizotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors