search
Back to results

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

Primary Purpose

ALK-Positive Anaplastic Large Cell Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Crizotinib
Etoposide Capsule
Auto-HSCT
Sponsored by
Mingzhi Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ALK-Positive Anaplastic Large Cell Lymphoma focused on measuring crizotinib, etoposide, autologous hematopoietic stem cell transplantation, ORR, OS, PFS, adverse events

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Department of The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crizotinib + etoposide capsule+Auto-HSCT

Arm Description

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.

Outcomes

Primary Outcome Measures

ORR
Objective Responder Rate
PFS
Progression Free Survival

Secondary Outcome Measures

OS
Overall Survival
adverse events
Number of patients with adverse events

Full Information

First Posted
September 23, 2018
Last Updated
October 12, 2018
Sponsor
Mingzhi Zhang
search

1. Study Identification

Unique Protocol Identification Number
NCT03707847
Brief Title
Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mingzhi Zhang

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALK-Positive Anaplastic Large Cell Lymphoma
Keywords
crizotinib, etoposide, autologous hematopoietic stem cell transplantation, ORR, OS, PFS, adverse events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crizotinib + etoposide capsule+Auto-HSCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Intervention Description
250mg, BID, PO
Intervention Type
Drug
Intervention Name(s)
Etoposide Capsule
Intervention Description
50mg, QD, PO, d1-10，21days for one cycle
Intervention Type
Procedure
Intervention Name(s)
Auto-HSCT
Intervention Description
Auto-HSCT will be performed with patients who have achieved CR or VGPR.
Primary Outcome Measure Information:
Title
ORR
Description
Objective Responder Rate
Time Frame
up to 24 months
Title
PFS
Description
Progression Free Survival
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
up to 24 months
Title
adverse events
Description
Number of patients with adverse events
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingzhi zhang, Pro,Dr
Phone
13838565629
Email
Mingzhi_zhang@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingzhi zhang
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Department of The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Pro,Dr
Phone
13838565629
Email
mingzhi_zhang@126.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs