CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation
Conditions
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.
Interventions
PROCEDUREthe 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.
Sponsors
First Affiliated Hospital of Harbin Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival at six months | six months | the disease free survival of the new model haplo-HSCT will be assessed at 6 months. |
| acute graft-versus-host disease | three months | we will examine the treatment-related acute GVHD at 3 months. |
Countries
China
Contacts
Primary Contactmin li li, master
Outcome results
None listed