Exploring the Benefits of Adding a New Drug, Post-transplant Cyclophosphamide, to Standard Treatment for Preventing Transplant Complications in Patients Receiving Stem Cells from Female Donors with a History of Pregnancy

Evaluation of Post-transplant Cyclophosphamide as an Addition to Standard Graft-versus-Host Disease Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplant Recipients with Parous Female Donors: A Phase III Non-randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N44

Enrollment

120

Registered

2024-12-30

Start date

2025-01-19

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Condition 1: Acute myeloblastic leukaemia. Condition 2: Acute lymphoblastic leukaemia. Acute myeloblastic leukemia Acute lymphoblastic leukemia [ALL]

Interventions

Intervention 1: Intervention group: patients undergoing stem cell transplantation will receive the center's standard GVHD prophylaxis regimen (which includes intravenous cyclosporine at a dosage of 3

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult patients between 18 and 55 years of age Diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) In complete remission (CR) Undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT) from a human leukocyte antigen (HLA)-identical sibling donor Donors with a history of previous pregnancy or miscarriage ECOG performance status of 2 or less Left ventricular ejection fraction (LVEF) of 45% or greater Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) of at least 60% of predicted values Adequate liver function, defined as total bilirubin levels of 3.0 mg/dL or less or the absence of clinically significant liver disease

Exclusion criteria

Exclusion criteria: Prior history of allogeneic or autologous transplantation CD3 count less than 150 x 10^6

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of grade 3-4 acute GVHD. Timepoint: until 100 days After the intervention. Method of measurement: Visiting the patient and lab tests.;Cumulative incidence of extensive chronic GVHD. Timepoint: From 100 days following the intervention. Method of measurement: Visiting the patient and lab tests.	—

Secondary

Measure	Time frame
Overall survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient.;One-year relapse rate. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique.;Disease-free survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Bone marrow biopsy.;GvHD-free survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.	—

Measure

Time frame

Overall survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient.;One-year relapse rate. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique.;Disease-free survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Bone marrow biopsy.;GvHD-free survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Barkhordar

Tehran University of Medical Sciences

barkhordarm.n@gmail.com0021 8490 3691

Outcome results

None listed

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