NCT03263767

Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC

Phase II Study Testing Prophylaxis Feasibility of Graft Versus Host Disease With Only High Dose Cyclophosphamide Post-transplantation for Patients Eligible to a Reduced-intensity Conditioning Regiment Prior to Allogenic Transplantation With a Compatible Familial or Non-familial Donor.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 after post-transplantation (day+ 3 and +4) not only for patients with HLA- haploidentical donor but also for patients with Human Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease after transplantation, allowing to consider stopping immunosuppressive treatment after the transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has already been completed in myeloablative transplantation in adult patients. This approach could enable to avoid in the end several complications related to long term immunosuppressive drugs administration, while promoting quicker immunity recovery.

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, Myelodysplasia , myelofibrosis, Chronic Myeoloid Leukemia..) because of better antitumoral activity in this setting.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Fludarabine	30 mg/m² Intravenous 5 days from Day-6 to Day-2
DRUG	Clofarabine	30 mg/m² Intravenous 5 days from Day-6 to Day-2
RADIATION	Full body irradiation	2 grays at Day-1
DRUG	Cyclophosphamide	14 mg/kg intravenous 2 days at Day - 6 and day -5
DRUG	Cyclophosphamide	50 mg/kg intravenous 2 days at day +3 and day +4
OTHER	stem cell transplantation	at D0 intraveinous Depending on donor : the stem cells will be extracted from blood (CD34+) or from bone marrow (CD34+ and nuclear cells)
OTHER	nuclear cells	CD3+ cells if needed after transplantation
DRUG	Thymoglobulin Injectable Product	At day -2 2.5 mg/kg for patients inclued after 14 dec 2020

Timeline

• Start date: 2018-01-15
• Primary completion: 2021-10-21
• Completion: 2022-06-21
• First posted: 2017-08-28
• Last updated: 2022-07-15

Locations

1 site across 1 country: France