None listed
Conditions
Interventions
None listed
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients aged 18 years or older with acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia who are in complete remission before undergoing allogeneic hematopoietic stem cell transplantation (allo-HCT). - Patients who lack HLA-matched related or unrelated donor and planning to undergo haploidentical donor transplantation (HIDT) (transplantation with an HLA-mismatch = 4/8 among HLA-A, -B, -C, and -DRB1). - Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. - Patients with adequate liver function (bilirubin =1.5 times the upper limit of normal (ULN) or transaminases =2.5 times ULN). - Patients with adequate renal function (creatinine =1.5 times ULN). - Patients with adequate cardiac function (left ventricular ejection fraction (LVEF) =40%). - Patients with adequate pulmonary function (diffusing capacity of the lungs for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) =50% of predicted value). - Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: - Patients with disease progression prior to transplantation (e.g., beyond first complete remission, relapse, or refractory disease). - Patients who have previously undergone autologous or allogeneic hematopoietic stem cell transplantation. - Patients with severe organ dysfunction (e.g., liver failure, cirrhosis, chronic viral hepatitis, renal failure, coronary artery disease, congestive heart failure, myocardial infarction, clinically significant arrhythmia, or requiring oxygen support). - Patients with uncontrolled active infections. - Patients with uncontrolled bleeding disorders. - Patients with uncontrolled psychiatric disorders. - Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use appropriate contraceptive methods during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;relapse (cumulative incidence);non-relapse mortality (cumulative incidence);acute graft-versus-host disease rate (cumulative incidence);chronic graft-versus-host disease rate (cumulative incidence) | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Ho Yoon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed