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

Phase 2

• Conditions: Hematologic Malignancy
• Interventions: Procedure: Myeloablative double unit cord blood transplantation

• Registration Number: NCT02385955
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11
• Study Start: 2015-04
• Primary Completion: 2017-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years

Secondary Outcome Measures

Name	Time	Method
Chronic graft-versus-host disease	2 years
Non-relapse mortality	2 years
Time to relapse or progression	2 years
Acute graft-versus-host disease	2 years
Time to engraftment	2 years
Progression-free survival	2 years
Other transplant-related serious adverse events	2 years