Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

Harbin Medical University

Status: Unknown

Conditions: the Haploidentical Hematopoietic Stem Cell Transplantation; CD19-chimeric Antigen Receptor T Cells; Relapsed and/or Refractory Acute Lymphoblastic Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03423706

CART

Details and patient eligibility

About

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）.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

new model of haplo-HSCT

Experimental group

Description:

use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion

Treatment:

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