Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Byung-Sik Cho

Criteria

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