Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT07193420
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Confirmed hematological malignancy with an indication for allogeneic HSCT
* Presence of a haploidentical donor willing to donate PBSC
* Patient planned to receive a thiotepa-based conditioning regimen
* Provision of written informed consent Affiliation to a social security system (excluding "Aide Médicale d'État")
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07193420
Study Brief:
Protocol Section:
NCT07193420