Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC
NCT ID: NCT03263767
Last Updated: 2022-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
47 participants
INTERVENTIONAL
2018-01-15
2022-06-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LYMPHOID HEMOPATHY without ATG
patients with lymphoid hemopathy
Fludarabine
30 mg/m² Intravenous 5 days from Day-6 to Day-2
Full body irradiation
2 grays at Day-1
Cyclophosphamide
14 mg/kg intravenous 2 days at Day - 6 and day -5
Cyclophosphamide
50 mg/kg intravenous 2 days at day +3 and day +4
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)
nuclear cells
CD3+ cells if needed after transplantation
MYELOID HEMOPATHY without ATG
patients with myeloid hemopathy
Clofarabine
30 mg/m² Intravenous 5 days from Day-6 to Day-2
Full body irradiation
2 grays at Day-1
Cyclophosphamide
14 mg/kg intravenous 2 days at Day - 6 and day -5
Cyclophosphamide
50 mg/kg intravenous 2 days at day +3 and day +4
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)
nuclear cells
CD3+ cells if needed after transplantation
LYMPHOID HEMOPATHY witH ATG
patients inclued after 14 dec 2020, received a conditionnement regimen with ATG on Day -2 to reduce GVHD GRADE 1-2 incidence
Fludarabine
30 mg/m² Intravenous 5 days from Day-6 to Day-2
Full body irradiation
2 grays at Day-1
Cyclophosphamide
14 mg/kg intravenous 2 days at Day - 6 and day -5
Cyclophosphamide
50 mg/kg intravenous 2 days at day +3 and day +4
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)
nuclear cells
CD3+ cells if needed after transplantation
Thymoglobulin Injectable Product
At day -2 2.5 mg/kg for patients inclued after 14 dec 2020
MYELOID HEMOPATHY with ATG
patients inclued after 14 dec 2020, received a conditionnement regimen with ATG on Day -2 to reduce GVHD GRADE 1-2 incidence
Clofarabine
30 mg/m² Intravenous 5 days from Day-6 to Day-2
Full body irradiation
2 grays at Day-1
Cyclophosphamide
14 mg/kg intravenous 2 days at Day - 6 and day -5
Cyclophosphamide
50 mg/kg intravenous 2 days at day +3 and day +4
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)
nuclear cells
CD3+ cells if needed after transplantation
Thymoglobulin Injectable Product
At day -2 2.5 mg/kg for patients inclued after 14 dec 2020
Interventions
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Fludarabine
30 mg/m² Intravenous 5 days from Day-6 to Day-2
Clofarabine
30 mg/m² Intravenous 5 days from Day-6 to Day-2
Full body irradiation
2 grays at Day-1
Cyclophosphamide
14 mg/kg intravenous 2 days at Day - 6 and day -5
Cyclophosphamide
50 mg/kg intravenous 2 days at day +3 and day +4
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)
nuclear cells
CD3+ cells if needed after transplantation
Thymoglobulin Injectable Product
At day -2 2.5 mg/kg for patients inclued after 14 dec 2020
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes Uh
Nantes, , France
Countries
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Other Identifiers
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RC16_0435
Identifier Type: -
Identifier Source: org_study_id
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