Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

Relapsed and/or Refractory Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03423706
• Other study ID #: CART
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: December 2021

Study information

• Verified date: January 2019
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: min li li, master
• Phone: 13796615495
• Email: llilimin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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）.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. the r/r B-ALL patients

2. have the healthy allo-HSCT donor

3. voluntary and signed the treatment protocol

Exclusion Criteria:

1. not match the inclusion criteria

2. important organ is dysfunction, such as heart and/or renal dysfunction,liver failure

3. Pregnancy or breast-feeding women

4. has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment

Related Conditions & MeSH terms

• CD19-chimeric Antigen Receptor T Cells
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Relapsed and/or Refractory Acute Lymphoblastic Leukemia
• the Haploidentical Hematopoietic Stem Cell Transplantation

Intervention

Procedure:
• the new model of haplo-HSCT for r/r B-ALL
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.

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival at six months	the disease free survival of the new model haplo-HSCT will be assessed at 6 months.	six months
Primary	acute graft-versus-host disease	we will examine the treatment-related acute GVHD at 3 months.	three months