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Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT03423706
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
CD19-chimeric Antigen Receptor T Cells Relapsed and/or Refractory Acute Lymphoblastic Leukemia the Haploidentical Hematopoietic Stem Cell Transplantation Procedure: the new model of haplo-HSCT for r/r B-ALL Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: new model of haplo-HSCT
use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion
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.




Primary Outcome Measures :
  1. disease free survival at six months [ Time Frame: six months ]
    the disease free survival of the new model haplo-HSCT will be assessed at 6 months.

  2. acute graft-versus-host disease [ Time Frame: three months ]
    we will examine the treatment-related acute GVHD at 3 months.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423706


Contacts
Contact: min li li, master 13796615495 llilimin@163.com

Locations
China, Heilongjiang
First affiliated hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150001
Contact: min li li, master    13796615495    llilimin@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
Study Chair: jin zhou, doctor First affliliated hospital of Harbin medical university

Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03423706     History of Changes
Other Study ID Numbers: CART
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases