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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT03263767
Eligibility Criteria:
Inclusion Criteria:
* adults ≤ 70 years old
* indication to stem cells transplantation with reduced-intensity conditioning regimen
* with a HLA-compatible familial 10/10 or non-familial donor
* Written signed informed consent form
* woman with childbearing potential under efficient control birth method during the trial and up to 12 months after cyclophosphamide stop
* men under efficient control birth method during the trial and up to 6 months after cyclophosphamide stop
* Negative serology to B and C hepatitis and to HIV
* Affiliated to social security
Exclusion Criteria:
* \- Eligible to myeloablative contioning regimen
* Other progressive malignancy disease or history of prior other malignancy in the last two years, with the exception of: curatively treated basal cell carcinoma or carcinoma in situ of the cervix
* Progressive mental illness disease
* Pregnant or Breastfeeding woman
* woman with childbearing potential without any efficient control birth
* Serious concomitant infection and not controlled
* Contra-indications to allogenic transplantation, especially:
* Cardiac: left ventricular ejection fraction \<45% assessed by transthoracic echography or isotopic method (isotopic gamma-angiography)
* Respiratory: DLCO limiting fludarabine and busulfan use (DLCO\< 40% of theorical value)
* Renal: creatinine clearance \< 60ml/min (MDRD method)
* Hepatic: transaminases \>5 Uper Per Normal (UPN) or bilirubin\> 2 UPN
* Contra-indications to cyclophosphamide:
* Urinary tract infections
* Acute urothelial toxicity due to cytotoxic chemotherapy or to radiotherapy
* Obstruction of urines flow
* Pre-existing hemorrhagic cystitis
* Yellow fever vaccination
* Cardiac condition preventing high dose cyclophosphamide utilization :
* New York Heart Association (NYHA) functional class II, III or IV
* Rhythmic, valvular or ischemic cardiomyopathy
* Minor
* Patient under guardianship or curatorship
* Patient under judicial protection
* Known or suspected hypersensitivity to cyclophosphamide
* Known or suspected hypersensitivity to rabbit proteins
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03263767
Study Brief:
Protocol Section:
NCT03263767