Hematologic Malignancy
Conditions
Brief summary
This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.
Interventions
PROCEDUREMyeloablative double unit cord blood transplantation
Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI, 12Gy), followed by cyclophosphamide (60 mg/kg/day on day -3 and -2) and cytarabine (3 g/m2 every 12 hours on day -5 and -4), or (2) thiotepa (5 mg/kg/day on day -7 and -6), busulfan (3.2 mg/kg/day on day -5, -4, and -3), and fludarabine (50 mg/m2/day on day -5, -4, and -3).
Sponsors
The Korean Society of Blood and Marrow Transplantation
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome * Patients who have suitable cord blood units for dUCBT * Patients with ECOG performance status 0-1 * Patients with adequate organ function: lung, kidney, liver, heart, etc. * Informed consent
Exclusion criteria
* Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors * Patients who have anti-HLA antibodies * Patients with any evidence of central nervous system (CNS) involvement of disease * Patients with uncontrolled diabetes * Patients with uncontrolled hypertension * Patients with any evidence of active infection * Positive for human immunodeficiency virus (HIV) * Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.) * Women who are pregnant or breastfeeding * Patients with previous history of allogeneic stem cell transplantation * Patients with major psychotic disorder or drug/alcohol abuser * Inappropriate patients according to the investigators' opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to relapse or progression | 2 years |
| Time to engraftment | 2 years |
| Acute graft-versus-host disease | 2 years |
| Progression-free survival | 2 years |
| Non-relapse mortality | 2 years |
| Other transplant-related serious adverse events | 2 years |
| Chronic graft-versus-host disease | 2 years |
Contacts
Primary ContactSung-Soo Yoon, MD, PhD
Backup ContactJunglim Lee, MD
Outcome results
None listed