Status:
TERMINATED
Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC
Lead Sponsor:
Nantes University Hospital
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Acute or chronic graft versus host disease is still the major complication of stem cells transplantation regarding morbidity and mortality. Recently, high dose cyclophosphamide utilization early afte...
Detailed Description
The BALTIMORE conditioning regiment will be used in this study with peripheral stem cell transplantation and fludarabine will be replaced by clofarabine for myeloid diseases (Acute Myeloide Leukemia, ...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03263767
Start Date
January 15 2018
End Date
June 21 2022
Last Update
July 15 2022
Active Locations (1)
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1
Nantes Uh
Nantes, France