FIBRAPLO - Haplo-identical transplantation in patients with myleofibrosis
Key facts
- Where
- Amiens Cedex 1, Angers, Besancon Cedex, Caen Cedex 9, Clermont Ferrand Cedex 1, Creteil Cedex, Grenoble Cedex 9, Lille Cedex, Limoges Cedex 1, Marseille, Montpellier Cedex 5, Nantes, Nice, Paris, Paris Cedex 13, Pessac, Pierre-Bénite, Rennes, Toulouse Cedex 9, Tours és Vandoeuvre Les Nancy, FranciaországSee the 21 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranciaországNo longer taking part
- Centre Hospitalier Universitaire D'AngersAngers, FranciaországNo longer taking part
- CHU BesanconBesancon Cedex, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranciaországNo longer taking part
- University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranciaországNo longer taking part
- Assistance Publique Hopitaux De ParisCreteil Cedex, FranciaországNo longer taking part
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De LilleLille Cedex, FranciaországNo longer taking part
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranciaországNo longer taking part
- Institut Paoli-CalmettesMarseille, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de NantesNantes, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de NiceNice, FranciaországNo longer taking part
- Assistance Publique Hopitaux de ParisParis, FranciaországNo longer taking part
- Assistance Publique Hopitaux De ParisParis Cedex 13, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországNo longer taking part
- Hospices Civils de LyonPierre-Bénite, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de RennesRennes, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországNo longer taking part
- Centre Hospitalier Régional Universitaire de ToursTours, FranciaországNo longer taking part
- CHRU De NancyVandoeuvre Les Nancy, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique Hopitaux De Paris
- Trial code
- EU 2024-513325-23-00
- Record updated
- 2024. július 23.
- Original description
The main objective is disease-free survival and without rejection one year after haplo-identical transplantation in patients with primary or secondary myelofibrosis.Read full original descriptionShow less
FIBRAPLO - Haplo-identical transplantation in patients with myleofibrosis : A phase 2 prospective multicentric prospective study
The main objective is disease-free survival and without rejection one year after haplo-identical transplantation in patients with primary or secondary myelofibrosis.
Inclusion: Patients aged between 18 and 70 years; Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia Vera proven by marrow biopsy; The myelofibrosis should combine at least 2 of the following criteria: o constitutional symptoms: weight loss > 10% in one year, fever (without infection), recurrent muscle, bone or join pains, extreme fatigue o anemia with hemoglobin < 10 gr/dL or red blood cell transfusion requirement o thrombocytopenia < 100 G/L o peripheral blast count > 1% at least found 2 times o white blood cell count > 25 G/L (before a cytoreductive treatment) o Karyotype: +8, -7/7q-, i(17q), -5, 5q-, 12p-, inv(3), 11q23; Performance status according to ECOG at 0, 1 or 2; With health insurance coverage; Having signed a written informed consent; Women agreed to take nomegestrol acetate as contraception during and up to 6 months after treatment by treosulfan; Men agreed not to conceive child during and up to 6 months after treatment by treosulfan.
Exclusion: Contraindications or any circumstance that precludes the use of the drugs involved in the protocol (especially Thiotepa and Fludarabine); Contraindications to treosulfan o Hypersensitivity to the active substance o Active non-controlled infectious disease o Fanconi anaemia and other DNA breakage repair disorders o Administration of live vaccine; Cardiac failure with EF < or = 50% currently or in the past (even if corrected after treatment); Renal failure with creatininemia > 130 µmol/L or clearance < 50ml/min; Biological significant liver abnormalities; ASAT or ALAT> 2 x normal range, bilirubin > 1,5 x normal range; Myelofibrosis transformed into acute leukemia; Pregnant woman or breastfeeding; Poor performance status with ECOG 3 or more; Respiratory function altered with vital capacity < 70% or forced expired volume < 70%; HLA matched donor available; Tutorship or curatorship; Unwilling or unable to comply with the protocol.