SYFa8eb8c7f30f34d5185cf4c3fdf38b86fRegistry ID: 2022-502019-12-00|RecruitingPhase 3
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interventional
N/A
1 country
23
To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2023
Actual (reported)OS is defined as the time from day 1 of the conditioning to death or last follow-up for survivors
-Engraftment: PNN >500/mm3 + donor chimerism >=5% (day +30/42) -Primary and secondary graft failure: donor chimerism <5% at day +30/42 post-transplant (primary) or at distance of transplant after achieving engraftment (secondary)
-Neutrophils recovery: the first of three consecutive days with neutrophils ≥500/mm3 after aplasia from day 0 of the graft -Platelets recovery: the first of three consecutive days with platelets ≥20000/mm3 without transfusion after aplasia from day 0 of the graft
DFS: time from day 1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
Relapse: any event related to progression or re-occurrence of the disease from day 1 of the conditioning
NRM: death from any cause without previous relapse or progression from day 1 of the conditioning
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
FLUDARABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
FLUCORTAC 50 microgrammes, comprimé sécable
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
CellCept 250 mg capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
CLOFARABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
BUSULFAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
FLUDARABINE
Named ingredient: fludarabine
View registry recordFLUCORTAC 50 microgrammes, comprimé sécable
Named ingredient: fludrocortisone acetate
View registry recordCellCept 250 mg capsules
Named ingredient: Mycophenolate mofetil
View registry recordCLOFARABINE
Named ingredient: Clofarabine
View registry recordBUSULFAN
Named ingredient: Busulfan
View registry recordNEORAL® Soft Gelatin Capsules 10mg
Named ingredient: Ciclosporin
View registry recordInstitut Paoli-Calmettes
Marseille, 13009, France
Hospices Civils De Lyon
Pierre-Benite, 69310, France
Centre Hospitalier Universitaire D Angers
Angers Cedex 9, 49933, France
Marion GAUTIER
First Submitted
February 2, 2023
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CONCENTRATE FOR SOLUTION FOR INFUSION
Formulated product
NEORAL® Soft Gelatin Capsules 10mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry recordContact the study team to confirm eligibility.
Limoges University Hospital Dupuytren 1
Limoges Cedex 1, 87042, France
Centre Hospitalier Universitaire De Montpellier
Montpellier Cedex 5, 34295, France
Centre Hospitalier Universitaire De Bordeaux
Pessac, 33600, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, 86000, France
Centre Hospitalier Universitaire De Saint Etienne
Saint-Priest-En-Jarez, 42270, France
Hopital Saint Louis
Paris, 75010, France
Assistance Publique Hopitaux De Paris
Creteil Cedex, 94010, France
Centre Hospitalier Regional Et Universitaire De Brest
Brest, 29200, France
Centre Hospitalier Universitaire De Rennes
Rennes Cedex 9, 35033, France
Hopital Huriez
Lille Cedex, 59045, France
University Hospital Of Clermont-Ferrand
Clermont-Ferrand, 63100, France
Hopital Saint Antoine
Paris Cedex 12, 75571, France
Centre Hospitalier Universitaire De Nantes
Nantes Cedex 1, 44093, France
Centre Hospitalier Universitaire Amiens Picardie
Amiens, 80054, France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble Cedex 9, 38043, France
Assistance Publique Hopitaux De Paris
Paris Cedex 13, 75651, France
Centre Hospitalier Universitaire De Caen Normandie
Caen Cedex 9, 14033, France
Besancon University Hospital Center
Besancon Cedex, 25030, France
Institut Universitaire Du Cancer Toulouse-Oncopole
Toulouse Cedex 9, 31059, France
CHRU De Nancy
Vandoeuvre Les Nancy, 54500, France