Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
NCT ID: NCT06252870
Last Updated: 2024-10-28
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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RECRUITING
PHASE2
82 participants
INTERVENTIONAL
2024-07-18
2028-07-18
Brief Summary
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Recently, in the context of semi-identical (=haploidentical) HLA donors, but also of compatible HLA donors, the use of cyclophosphamide (CY) administered in high doses at early post-transplant (PT) (=PTCY) (Days +3 and +4 or +5) has shown excellent control of acute and chronic GVH, even enabling the discontinuation of other immunosuppressive drugs administered after allo-CSH (ciclosporin, mycophenolate mofetyl (MMF) or Cellcept).
This step has already been taken in the context of allo-CSH with myeloablative conditioning (MAC), which is a minoritary conditioning in adults.
However, in the context of allo-CSH with reduced-intensity conditioning (RIC), which predominates in adults, this strategy seems insufficient to prevent the risk of GVHD.
The idea of reducing the use of immunosuppressants in the context of RIC/HLA-compatible transplants seems, however, still relevant, in order to reduce their adverse effects, improve patients' quality of life and enhance the reconstitution of the post-transplant immune system.
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Detailed Description
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The investigators hypothesize that administration of this PTCY+MTX combination will enable immunosuppressive drugs to be discontinued as early as D+11 post-transplant, compared with the usual average of 3 to 4 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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(CLO)-BALTIMORE
BALTIMORE conditioning regime for LYMPHOID HEMOPATHY CLO-BALTIMORE conditioning regime for MYELOID HEMOPATHY
Methotrexate
15 mg/m² on Day+1 after graft (=Day0) 10 mg/m² 3 days on Day+4/Day+6/Day+11 after graft (=Day0)
Post-Transplant Cyclophosphamide
50 mg/kg intravenous 2 days on Day+3/Day+5 after graft (=Day0)
Fludarabine
Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0)
Cycophosphamide
Conditioning regimen: 14.5 mg/kg intravenous 2 days on Day-6/Day-5 before graft (=Day0)
Anti-Thymoglobulin
Conditioning regimen: 2.5 mg/kg intravenous on Day-2 before graft (=Day0)
total body irradiation
2 grays on Day-1 before graft (=Day0)
hematopoietic stem cells
High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft)
Graft nuclear cells
Graft nuclear cells CD3+ cells if needed after transplantation
Donor Lymphocytes Injection
DLI with CD3+ if relapse after transplantation or in prevention of relapse
Clofarabine
Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0)
TBF
Conditioning regimen for LYMPHOID AND MYELOID HEMOPATHY
Methotrexate
15 mg/m² on Day+1 after graft (=Day0) 10 mg/m² 3 days on Day+4/Day+6/Day+11 after graft (=Day0)
Post-Transplant Cyclophosphamide
50 mg/kg intravenous 2 days on Day+3/Day+5 after graft (=Day0)
Anti-Thymoglobulin
Conditioning regimen: 2.5 mg/kg intravenous on Day-2 before graft (=Day0)
hematopoietic stem cells
High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft)
Graft nuclear cells
Graft nuclear cells CD3+ cells if needed after transplantation
Donor Lymphocytes Injection
DLI with CD3+ if relapse after transplantation or in prevention of relapse
Thiotepa
Conditioning regimen: 5 mg/kg Intravenous at Day-6 before graft (=Day0)
Busulfan
Conditioning regimen: 3.2 mg/kg Intravenous 2 days at Day-2 and Day-1 before graft (=Day0)
Fludarabine
Conditioning regimen: 40 mg/m² intravenous 4 days on Day-5/Day-4/Day-3/Day-2 before graft (=Day0)
Interventions
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Methotrexate
15 mg/m² on Day+1 after graft (=Day0) 10 mg/m² 3 days on Day+4/Day+6/Day+11 after graft (=Day0)
Post-Transplant Cyclophosphamide
50 mg/kg intravenous 2 days on Day+3/Day+5 after graft (=Day0)
Fludarabine
Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0)
Cycophosphamide
Conditioning regimen: 14.5 mg/kg intravenous 2 days on Day-6/Day-5 before graft (=Day0)
Anti-Thymoglobulin
Conditioning regimen: 2.5 mg/kg intravenous on Day-2 before graft (=Day0)
total body irradiation
2 grays on Day-1 before graft (=Day0)
hematopoietic stem cells
High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft)
Graft nuclear cells
Graft nuclear cells CD3+ cells if needed after transplantation
Donor Lymphocytes Injection
DLI with CD3+ if relapse after transplantation or in prevention of relapse
Clofarabine
Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0)
Thiotepa
Conditioning regimen: 5 mg/kg Intravenous at Day-6 before graft (=Day0)
Busulfan
Conditioning regimen: 3.2 mg/kg Intravenous 2 days at Day-2 and Day-1 before graft (=Day0)
Fludarabine
Conditioning regimen: 40 mg/m² intravenous 4 days on Day-5/Day-4/Day-3/Day-2 before graft (=Day0)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with hematologic malignancy
* Indication for HSC allograft with attenuated conditioning
* Pluripotent stem cell (PSC) engraftment
* Availability of a 10/10 familial or non-familial HLA compatible donor
* Consent to the protocol
* ECOG \<=2
* Woman of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for a period of 12 months after stopping MTX and CY
* Man of childbearing age with highly effective contraception during treatment and for a period of 6 months after stopping MTX and CY and a period of 12 months after stopping MTX and CY if TBF conditioning regimen arm
* Negative Hepatitis B, C, HIV serologies
* Social security affiliation
Exclusion Criteria
* Patient eligible for myeloablative conditioning (MAC)
* Bone marrow transplant
* Other progressive cancerous disease, or antecedent of cancer in the last five years, with the exception of a carcinoma of the skin or a carcinoma in situ of the uterine cole treated and in remission.
* Progressive psychiatric condition
* Pregnant or breastfeeding woman,
* Woman or man of childbearing age with lack of effective contraception
* Serious and uncontrolled concomitant infection
* Cardiac: systolic ejection fraction \< 50% by transthoracic ultrasound or by isotopic method (isotope gamma angiography), NYHA II, III or IV heart failure, active rhythmic, valvular or ischemic heart disease or anteriority
* Respiratory with EFR: DLCOc \<40% of theoretical
* Renal: creatinine clearance \< 50 ml/min (assessment with MDRD method)
* Urological: active urinary tract infection, history of acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy, known obstruction of urinary flow, pre-existing hemorrhagic cystitis
* Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal
* Person protected by law (major under guardianship, curatorship or legal protection)
* Vaccination against yellow fever in the last year
* Known or suspected hypersensitivity to rabbit proteins as well as to the active substance and excipients of all investigational and ancillary drugs administered during the study,
* Contraindication to any of the investigational or adjuvant drugs administered during the study
* Patient not speaking French
18 Years
70 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Sylvain THEPOT, MD
Role: PRINCIPAL_INVESTIGATOR
Angers University Hospital
Marie-Anne COUTURIER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Brest
Locations
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CHU Angers
Angers, , France
CHU Brest
Brest, , France
CHU Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC23_0286
Identifier Type: -
Identifier Source: org_study_id
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