Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

Not Applicable

• Conditions: Relapsed and/or Refractory Acute Lymphoblastic Leukemia; CD19-chimeric Antigen Receptor T Cells; the Haploidentical Hematopoietic Stem Cell Transplantation
• Interventions: Procedure: the new model of haplo-HSCT for r/r B-ALL

• Registration Number: NCT03423706
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

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.

Study Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-06
• Study Start: 2018-05-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-17
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

First affiliated hospital of Harbin medical university; 🇨🇳 Harbin, Heilongjiang, China