Lymphoma Clinical Trial
Official title:
A Phase II Prospective Randomized Trial of Donor T-memory Cells (CD45RA Depleted) Infusion for Prevention of Infections After Allogeneic TcRαβ/CD19-depleted Hematopoietic Stem Cell Transplantation
The purpose of this prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).
Status | Completed |
Enrollment | 150 |
Est. completion date | August 21, 2020 |
Est. primary completion date | August 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 25 Years |
Eligibility | Inclusion Criteria: - Patients who are considered candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses: - Acute lymphocytic leukemia (ALL) - Acute myeloid leukemia - Acute biphenotypic leukemia - Acute bilinear leukemia - Lymphoma - Myelodysplastic syndrome - Chronic myeloid leukemia - Transplant processing: TCR ab/CD19-depletion - Donors: - HLA-match unrelated volunteers - Partly and haploidentical relative Exclusion Criteria: - ALL patients not in remission - Patients with uncontrolled infections - Clearance of creatinine < 70 ml/min - Cardiac ejection fraction < 40% - Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of < 50% predicted; patients who are unable to perform pulmonary function tests will be excluded if the oxygen (O2) saturation is < 92% on room air - Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal - Mental disease of both patient, patient's tutor (if patient is under age 18) and donor, that hinder understanding of main point of the study and keeping treatment plan, hygiene and sanitation |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal Research Center for pediatric hematology, 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 | cumulative incidence of the probability of CMV-reactivation after HSCT | 120 days after HSCT | ||
Primary | cumulative incidence of acute GVHD grade II-IV. | 150 days after HSCT | ||
Secondary | cumulative incidence of of CMV-disease at 100,180 and 365 days after HSCT | 100, 180 and 365 days after HSCT | ||
Secondary | overall survival at 365 days after HSCT | 365 days after HSCT | ||
Secondary | Event-free survival at 365 days after HSCT | 365 days after HSCT | ||
Secondary | cumulative incidence of relapse at 6 months and 365 days after HSCT | 6 months and 365 days | ||
Secondary | cumulative incidence of transplant-related mortality at 6 months after HSCT | 6 months | ||
Secondary | cumulative incidence of chronic GvHD | 1 year after HSCT | ||
Secondary | cumulative incidence of neutrophil and platelets engraftment at 14 and 30 days after HSCT | 14 and 30 days |
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