Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Hematologic Malignancy

Treatments: Procedure: Myeloablative double unit cord blood transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02385955

KSBMT200809

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

Myeloablative dUCBT

Experimental group

Description:

Myeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant

Treatment:

Procedure: Myeloablative double unit cord blood transplantation