- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03707847
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Henan
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Zhengzhou, Henan, China, 450052
- Recruiting
- Oncology Department of The First Affiliated Hospital of Zhengzhou University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: up to 24 months
|
Objective Responder Rate
|
up to 24 months
|
PFS
Time Frame: up to 24 months
|
Progression Free Survival
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: up to 24 months
|
Overall Survival
|
up to 24 months
|
adverse events
Time Frame: up to 24 months
|
Number of patients with adverse events
|
up to 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma
- Lymphoma, Large-Cell, Anaplastic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Etoposide
- Crizotinib
Other Study ID Numbers
- hnslblzlzx20180821
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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