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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230801058996N4
Enrollment
12
Registered
2024-06-19
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute leukemia. Acute leukemia of unspecified cell type

Interventions

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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Transplantation of T cell replete haplotype with cyclophosphamide The estimated life expectancy more than one year Karnofsky index above 70%

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Roshandel

Shahid Beheshti University of Medical Sciences

elham.roshandel@gmail.com+98 21 2303 1658

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026