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IRCT20230801058996N4 IRCT 2024-06-19 Shahid Beheshti University of Medical Sciences Reducing infection risk in adult patients with acute leukemia using modified donor lymphocyte infusion (DLI) following allogeneic hematopoietic stem cell transplantation Safety and efficacy of modified donor lymphocyte infusion (DLI) in reducing infection risk in adult patients with acute leukemia following allogeneic hematopoietic stem cell transplantation 2024-07-05 anticipated 12 Recruiting https://irct.ir/trial/77382 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 1-2 Acute leukemia. Intervention 1: Intervention group: Acute leukemia patients receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy) and then modified DLI with time intervals of 4-6 weeks with escalating doses of 0.5 x 106, 1 x 106 and 3 x 106 they receive. Intervention 2: Control group: Acute leukemia patients only receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy). No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patient information
public Elham Roshandel
Aarabi street, Yaman street, Chamran highway
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۱۱۵۱ +98 21 2303 1658 elham.roshandel@gmail.com Shahid Beheshti University of Medical Sciences scientific Elham Roshandel
Aarabi street, Yaman street, Chamran highway
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۱۱۵۱ +98 21 2303 1658 elham.roshandel@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Transplantation of T cell replete haplotype with cyclophosphamide The estimated life expectancy more than one year Karnofsky index above 70% 20 years 70 years Both GVHD of grade 2 or less Uncontrolled bacterial infection Insufficient intake: WBC<2500/mm3 and Platelet<50000/mm3 Evidence of recurrence Concomitant treatment with corticosteroids and/or other immunosuppressive drugs Infection with hepatitis B, C and HIV pathogens C95.0 Acute leukemia of unspecified cell type Treatment - Other Treatment - Other Intervention group: Acute leukemia patients receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy) and then modified DLI with time intervals of 4-6 weeks with escalating doses of 0.5 x 106, 1 x 106 and 3 x 106 they receive. Control group: Acute leukemia patients only receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy). Infection rate after treatment with modified DLI. Timepoint: From the first dose of modified DLI infusion until one year after its last dose on days 90, 180, and 360. Method of measurement: Examining clinical symptoms, performing laboratory tests for viral infections, performing laboratory tests for bacterial and fungal infections in case of clinical symptoms. Evaluation of "Overall survival" in a one year period. Timepoint: From the first dose of modified DLI infusion until one year after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Shahid Beheshti University of Medical Sciences Javidan Motaher Charity Foundation of Tehran Pharmed Behin Azma Approved 2024-04-28 کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی Taleghani Hospital, Aarabi street, Yaman street, Chamran highway Tehran Tehran Iran (Islamic Republic of)