Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 August 2016 |
Main ID: |
NCT02327351 |
Date of registration:
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18/12/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID
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Scientific title:
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Phase II/III Study of Allogeneic Hematopoietic Stem Cell Transplantation From Unrelated and Haploidentical Donors After TCR Alfa Beta Negative Selection in Pediatric Patients With Primary Immunodeficiency Diseases |
Date of first enrolment:
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July 2012 |
Target sample size:
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60 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02327351 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Dmitry Balashov, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology |
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Name:
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Alexei Maschan, Professor |
Address:
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Telephone:
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Email:
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Affiliation:
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Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology |
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Name:
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Dmitry Balashov, MD, PhD |
Address:
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Telephone:
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+7(495)287-6570 |
Email:
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bala8@yandex.ru |
Affiliation:
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Name:
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Dmitry Balashov, MD, PhD |
Address:
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Telephone:
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+7(495)287-6570 |
Email:
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bala8@yandex.ru |
Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
1 Month
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hematopoietic Stem Cell Transplantation
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Primary Immune Deficiency Disorder
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Intervention(s)
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Other: Biological: TCR alfa beta T cell depletion
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Primary Outcome(s)
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Overall survival (OS)
[Time Frame: up to 24 months after transplantation]
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Secondary Outcome(s)
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Transplant related mortality (TRM)
[Time Frame: up to 24 months after transplantation]
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Cellular Immunological reconstitution by laboratory evaluations
[Time Frame: up to 24 months after transplantation]
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Percentage of patients with full/mixed donor chimerism
[Time Frame: up to 12 months after transplantation]
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Acute graft versus host diseases (?GVHD)
[Time Frame: up to 12 months after transplantation]
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Chronic graft versus host diseases (cGVHD)
[Time Frame: up to 24 months after transplantation]
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Viral infections after transplant
[Time Frame: up to 12 months after transplantation]
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Secondary ID(s)
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TCRabPID-2012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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