ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude

Situation thérapeutique : Greffe

Traitement :

Cadre réglementaire : RIPH1

Dernière MÀJ : 23/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude randomisée de phase III de greffe allogénique comparant la greffe à partir d'un donneur familial partiellement compatible ou d'un donneur non familial chez des patients âgés

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées
Informations complémentaires
Schéma : he MAC-HAPLO-MUD trial is a randomized prospective phase III trial comparing HLA 10/10 matched unrelated donor and haploidentical allogeneic hematopoietic stem cell transplantation after myeloablative conditioning regimen in patients, age 15 years or older, with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) or Myeloproliferative Syndrome (SMP) or Myelodysplastic Syndromes (SMD) and requiring allogeneic hematopoietic stem cell transplantation. Primary endpoint is the 1-year progression free survival without acute grade II-IV GvHD and without moderate and severe chronic GvHD.

2 arms:
- Experimental: Haploidentical donor stem cell transplantation
The stem cell source will be bone marrow for haploidentical transplantation.The bone marrow collection is carried out according to the practice of each centre with a minimal target dose of 3x108 TNC/kg.
- Active Comparator: HLA 10/10 MUD stem cell transplantation
The stem cell source will be peripheral blood stem cell for HLA-matched unrelated transplantation.Peripheral blood stem cell (PBSC) for HLA-matched unrelated SCT will be mobilized by G-CSF (Neupogen®) administered to the donor from Day-4 to Day-1 subcutaneously (10µg/kg/day) with the minimal target dose of 4.106 CD34+ cells/kg.

Phase : III

Stade : NA

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - With AML/ALL/SMD/SMP requiring allogeneic stem cell transplantation
- In complete response (CR) for AML/ALL or in CR, or partial response (PR) or non pre-treated for SMD/SMP *
- Without a HLA matched related donor available
- With a good probability to have a HLA-10/10 matched donor available (the patient needs to have at least 5 MUD identified within the book "BMDW (Bone Marrow Donors Worldwide)"
- With identification of a haploidentical donor (brother, sister, parents, adult children or cousin)
- Absence of donor specific antibody (DSA) detected in the patient with a MFI ≥ 2000 (antibodies directed towards the distinct haplotype between donor and recipient)
- With usual criteria for hematopoietic stem cell transplant (HSCT):
-> Eastern Cooperative Oncology Group (ECOG) ≤ 2
-> No severe and uncontrolled infection
-> Cardiac function compatible with high dose of cyclophosphamide
-> Adequate organ function: aspartate transaminase (ASAT) and alanine aminotransferase (ALAT) ≤ 2N, total bilirubin ≤ 1.5N, creatinine clearance ≥30ml/min (except if those abnormalities are linked to the hematological disease)
- With health insurance coverage
- Understand informed consent or optimal treatment and follow-up
- Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment and within 12 months for women and 6 months for men after the last dose of cyclophosphamide
- Having signed a written informed consent (2 parents for patients aged less than 18)

Critères de non-inclusion : - Presence of donor specific antibody (DSA) with a MFI ≥ 2000 detected in the patient
- History of Cancer in the last 5 years (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix)
- Uncontrolled infection
- Seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive polymerase chain reaction (PCR) hepatitis B virus (HBV) or hepatitis C virus (HCV) and hepatic cytolysis due to HBV
- Yellow fever vaccine within 2 months before transplantation
- Uncontrolled coronary insufficiency, recent myocardial infarction <6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction <50%
- Heart failure according to New York Heart Association (NYHA) (II or more)
- Urinary tract obstruction
- Contraindications to treatments used during the research
- Preexisting acute hemorrhagic cystitis
- Renal failure with creatinine clearance <30ml / min
- Pregnancy ( β- human chorionic gonadotropin (β-HCG positive)) or breast-feeding
- Any debilitating medical or psychiatric illness which would preclude the realization of the SCT or the understanding of the protocol
- Under protection by law (tutorship or curatorship)
- Unwilling or unable to comply with the protocol
Informations relatives au promoteur
Promoteur :
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Institut d'Hématologie Bas-Normand (IHBN) - Avenue de la Cote de Nacre - 14000 CAEN

Investigateur :
Gandhi Laurent DAMAJ

Marie-Charlotte ZAPALOWICZ

Statut de l'essai : OUVERT

MAJ : 23/12/2020