Clinical trial · Interventional

HLA 10/10 Matched Unrelated Donor vs Haploidentical Allogenic Hematopoietic Stem Cell Transplantation

Randomized Prospective Phase III Clinical Trial Comparing HLA 10/10 Matched Unrelated Donor and Haploidentical Allogenic Hematopoietic Stem Cell Transplantation After Myeloablative Conditioning Regimen

NCT03655145CI-TRIAL-00034665MacHaploMudunknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The 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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Lymphoblastic Leukemia	Acute Lymphoblastic Leukemia	ONTOLOGY_EXACT	0.98
Acute Myeloid Leukemia	Acute Myeloid Leukemia	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Myeloproliferative Syndromes	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Haplo donor stem cell transplantation	Other	—	UNRESOLVED
HLA 10/10 MUD stem cell transplantation	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Haploidentical donor stem cell transplantation
description
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.
interventionNames
1. Other: Haplo donor stem cell transplantation
type
ACTIVE_COMPARATOR
label
HLA 10/10 MUD stem cell transplantation
description
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.
interventionNames
1. Other: HLA 10/10 MUD stem cell transplantation

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 15 Years
Maximum age: 55 Years

Show eligibility criteria text

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

References

Publications (0)

Data not yet available

No reference posted for this study.