Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies

Exclusion Criteria

• •Karnofsky performance status \< 70%
• •Life expectancy \< 1 month, as determined by the attending physician
• •Acute or chronic heart failure, defined as left ventricular ejection fraction \< 40%
• •Pulmonary dysfunction with diffusion capacity \< 50% of predicted values
• •Renal impairment with estimated glomerular filtration rate (eGFR) \< 45 mL/min (calculated using the CKD-EPI formula)
• •Decompensated hemolytic anemia
• •Fanconi anemia and other DNA breakage repair disorders
• •Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy
• •Obstruction of urinary outflow
• •Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
• •Combination with products containing Hypericum perforatum
• •Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren
• •Active non-controlled infectious disease
• •Positive HIV status
• •Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose
• •Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)
• •Hypersensitivity to the active substance or any of the excipients
• •Concurrent participation in another investigational therapeutic study
• •Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to:
• •* Significant language barrier in the absence of adequate translation support
• •* Social or geographic situation preventing follow-up and adherence to visit schedule
• •* Ongoing substance abuse likely to interfere with protocol compliance
• •* Documented cognitive or functional impairment not otherwise covered under legal protection