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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02327351
Other study ID # TCRabPID-2012
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 2012
Est. completion date June 2018

Study information

Verified date February 2021
Source Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and unrelated donors in patients with primary immunodeficiency diseases


Description:

Infections, graft versus host diseases (GVHD) and associated morbidity and mortality remains significant problems after unrelated and haploidentical hematopoietic stem sell transplantation (HSCT) in patients with primary immunodeficiency diseases (PID). In this study the hypothesis is that the transplantation of TCR alfa beta depleted peripheral blood stem cells (PBSC) would offers advantages over the use of positively selected CD34+ stem cells in haploidentical HSCT and non-manipulated graft in unrelated HSCT. The purpose of this study is to evaluate the safety and efficiency of the selective infusion of TCR alfa beta T cell depleted graft in pediatric patients with PID receiving HSCT from haploidentical and unrelated donors.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - Patients aged = 1 months and < 19 years - Patients diagnosed with Primary Immunodeficiency Diseases eligible for an allogeneic transplantation and lacking a related HLA-matched donor - Lansky/Karnofsky score > 40, WHO > 4 - Signed written informed consent Exclusion Criteria: - Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance < 30 ml / min) - Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40%) - Serious concurrent uncontrolled medical disorder - Pregnant or breast feeding female patient - Lack of parents' informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biological: TCR alfa beta T cell depletion


Locations

Country Name City State
Russian Federation Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology Moscow

Sponsors (1)

Lead Sponsor Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival The probability of overall survival estimated by the Kaplan-Meier method at 1 year after HSCT 1 year after HSCT
Secondary Transplant Related Mortality (TRM) transplant-related mortality estimated with cumulative incidence curve, considering relapse as a competitive risk 24 months after transplantation
Secondary Acute Graft Versus Host Diseases (?GVHD) incidence of aGVHD II-IV stage estimated with cumulative incidence curve, considering graft rejection and death as competitive risks 12 months after transplantation
Secondary Chronic Graft Versus Host Diseases (cGVHD) incidence of cGVHD estimated with cumulative incidence curve, considering graft rejection and death as competitive risks 1 year after HSCT
Secondary Cellular Immunological Reconstitution Number of participants, who reached immune recovery - CD19+ lymphocytes subsets 2 years after HSCT
Secondary Percentage of Patients With Full Donor Chimerism Percentage of patients with full (more than 90%) donor chimerism among survivals last follow-up
Secondary Viral Infections After Transplant number of patients with CMV reactivation (detection of any grade of CMV viremia after HSCT) 12 months after transplantation
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