Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors

This study will compare the clinical outcomes of transplants from family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings 1. Primary objectives: Overall survival of FMT may be similar to that of MUT 2. Secondary objectives: i. Comparison of disease-free survival, relapse, non-relapse mortality, immune reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease between FMT and MUT. ii. Investigation of possible biomarkers related with above events after transplantation

Sex

All

Minimum age

17 Years

Maximum age

65 Years

Inclusion Criteria

* Patients with AML aged from 18 to 65 years
* Eastern Cooperative Oncology Group (ECOG) performance \< 2
* High risk group for relapse

  1. Complete remission (CR) 1 with unfavorable prognostic factor; presenting white blood cell \> 100,000/microliter or prior myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) or MDS/MPN or cytogenetics \& molecular features (intermediate and adverse)
  2. CR2 or CR3 at transplantation
* No HLA-matched sibling and unrelated donor (HLA-A, -B, -C, and -DRB1)
* Acceptable organ function defined as serum creatinine \< 2 mg/dl, unless considered due to leukemia and serum bilirubin \< 3 mg/dl, unless considered due to leukemia
* Written informed consent form

Exclusion Criteria

* Active uncontrolled infections
* Corrected pulmonary diffusion capacity of \<40%
* Cardiac ejection fraction of \<35%
* ECOG performance status :2, 3, 4
* Active central nervous system involvement of disease
* Serological evidence of infection with HIV
* Pregnancy or breastfeeding
* Patient who are not suitable for the trial in accordance with principal investigator's decision

• BACKGROUNDAversa F. Haploidentical haematopoietic stem cell transplantation for acute leukaemia in adults: experience in Europe and the United States. Bone Marrow Transplant. 2008 Mar;41(5):473-81. doi: 10.1038/sj.bmt.1705966. Epub 2008 Jan 7. PMID 18176612
• BACKGROUNDRuggeri A, Ciceri F, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of the European Blood and Marrow Transplant Group. Alternative donors hematopoietic stem cells transplantation for adults with acute myeloid leukemia: Umbilical cord blood or haploidentical donors? Best Pract Res Clin Haematol. 2010 Jun;23(2):207-16. doi: 10.1016/j.beha.2010.06.002. PMID 20837332
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• BACKGROUNDAnasetti C, Hansen JA. Effect of HLA incompatibility in marrow transplantation from unrelated and HLA-mismatched related donors. Transfus Sci. 1994 Sep;15(3):221-30. doi: 10.1016/0955-3886(94)90134-1. PMID 10155543
• BACKGROUNDHenslee-Downey PJ, Abhyankar SH, Parrish RS, Pati AR, Godder KT, Neglia WJ, Goon-Johnson KS, Geier SS, Lee CG, Gee AP. Use of partially mismatched related donors extends access to allogeneic marrow transplant. Blood. 1997 May 15;89(10):3864-72.