Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

NCT ID: NCT03423706

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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new model of haplo-HSCT

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. the r/r B-ALL patients
2. have the healthy allo-HSCT donor
3. voluntary and signed the treatment protocol

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jin zhou, doctor

Role: STUDY_CHAIR

First affliliated hospital of Harbin medical university

Locations

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First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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min li li, master

Role: CONTACT

Phone: 13796615495

Email: [email protected]

Facility Contacts

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min li li, master

Role: primary

Other Identifiers

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CART

Identifier Type: -

Identifier Source: org_study_id