Back to resultsClinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Primary Purpose
CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the new model of haplo-HSCT for r/r B-ALL
Sponsored by
About this trial
This is an interventional treatment trial for CD19-chimeric Antigen Receptor T Cells
Eligibility Criteria
Inclusion Criteria:
- the r/r B-ALL patients
- have the healthy allo-HSCT donor
- voluntary and signed the treatment protocol
Exclusion Criteria:
- not match the inclusion criteria
- important organ is dysfunction, such as heart and/or renal dysfunction,liver failure
- Pregnancy or breast-feeding women
- has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment
Sites / Locations
- First affiliated hospital of Harbin medical universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
new model of haplo-HSCT
Arm Description
use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion
Outcomes
Primary Outcome Measures
disease free survival at six months
the disease free survival of the new model haplo-HSCT will be assessed at 6 months.
acute graft-versus-host disease
we will examine the treatment-related acute GVHD at 3 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT03423706
First Posted
January 16, 2018
Last Updated
December 16, 2019
Sponsor
First Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03423706
Brief Title
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Official Title
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.
Detailed Description
compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
new model of haplo-HSCT
Arm Type
Experimental
Arm Description
use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion
Intervention Type
Procedure
Intervention Name(s)
the new model of haplo-HSCT for r/r B-ALL
Intervention Description
take advantage of high-dose CTX、CD19-CART、donor CD34+HSC and Tregs to create a new model of haplo-HSCT for the patients in r/r B-ALL,to improve the quality of HSCT.
Primary Outcome Measure Information:
Title
disease free survival at six months
Description
the disease free survival of the new model haplo-HSCT will be assessed at 6 months.
Time Frame
six months
Title
acute graft-versus-host disease
Description
we will examine the treatment-related acute GVHD at 3 months.
Time Frame
three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the r/r B-ALL patients
have the healthy allo-HSCT donor
voluntary and signed the treatment protocol
Exclusion Criteria:
not match the inclusion criteria
important organ is dysfunction, such as heart and/or renal dysfunction,liver failure
Pregnancy or breast-feeding women
has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
min li li, master
Phone
13796615495
Email
llilimin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jin zhou, doctor
Organizational Affiliation
First affliliated hospital of Harbin medical university
Official's Role
Study Chair
Facility Information:
Facility Name
First affiliated hospital of Harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
min li li, master
Phone
13796615495
Email
llilimin@163.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
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