Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
A Trial of Plerixafor With G-CSF as Additional Agents in Conditioning Regimen for Prevention of Graft Failure After Transplantation With TCR Alpha/Beta Grafts Depletion in Patients With Wiskott-Aldrich Syndrome.
NCT number | NCT03019809 |
Other study ID # | WAS_PG 2016 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | July 2019 |
Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after transplantation with TCR alpha/beta grafts depletion in patient with Wiskott-Aldrich syndrome.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 19 Years |
Eligibility |
Inclusion Criteria: - Patients aged = 1 months and < 19 years - Patients diagnosed with Wiskott-Aldrich syndrome 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 - Lack of parents' informed consent. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event free survival (EFS) | The EFS probability compared with historical control. We mean event as patient's death, second transplantation or persistence of severe thrombocytopenia | 24 months | |
Secondary | Overall survival (OS) | The OS probability compared with historical control. | 24 months | |
Secondary | Percentage of patients with full/mixed donor chimerism | Evaluation of the percentage of patients with the full/mixed donor chimerism (whole blood and CD3+ lineage). In addition, patients will be divided in accordance with % of donors cells: >95%; 50%-95%; 10%-49%; <10%. All data will be compared with historical control | 12 months | |
Secondary | Transplant related mortality (TRM) | The TRM probability compared with historical control. | 24 months | |
Secondary | Severe thrombocytopenia (ST) | The ST probability after HSCT compared with historical control | 24 months | |
Secondary | Autoimmune complications (AC) | The AC probability after HSCT compared with historical control | 24 months | |
Secondary | Acute Graft Versus Host Diseases (aGVHD) | Cumulative Incidence and severity of aGVHD | 12 months | |
Secondary | Chronic Graft Versus Host Diseases (cGVHD) | Cumulative Incidence and severity of cGVHD | 24 months | |
Secondary | Plerixafor related complications (PRC) | PRC: severity, features, incidence | 2 week |
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