Double Unit Cord Blood Transplant in Hematologic Malignancies.

PROspective Multicenter Observational Study of Double Unit Umbilical Cord Lood Transplantation in Korean Adult Patients With Hematologic Diseases.

The efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective observation and analysis of actual clinical data collection

Study Overview

• Status: Recruiting
• Conditions: Adult Double Unit Cord Blood Transplant
• Intervention / Treatment: Procedure: tranplant

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Dong-Yeop Shin, MD, PhD.; Phone Number: +82-2-2072-7209; Email: shindongyeop@snu.ac.kr

Study Locations

• South Korea
  • Daegu, South Korea
    • Not yet recruiting
    • Keimyung Unversity Dongsan Hospital
    • Contact: Young Rok Do
    • Principal Investigator: Young Rok Do
  • Pusan, South Korea
    • Not yet recruiting
    • Pusan National University Hospital
    • Principal Investigator: Ho Jin Shin
    • Contact: Do Young Kim
    • Sub-Investigator: Do Young Kim
  • Pusan, South Korea
    • Not yet recruiting
    • Dong-A University Hospital
    • Contact: Sung Hyun Kim
    • Principal Investigator: Sung Hyun Kim
    • Sub-Investigator: Ji Hyun Lee
  • Seongnam, South Korea
    • Not yet recruiting
    • Seoul National University Bundang Hospital
    • Contact: Soo Mee Bang
    • Principal Investigator: Soo Mee Bang
    • Sub-Investigator: Jeong Ok Lee
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Sung-Soo Yoon
    • Contact: Dong-Yeop Shin, MD, PhD
    • Contact: Eunhee Park, RN
    • Principal Investigator: Dong-Yeop Shin
    • Sub-Investigator: Junshik Hong
    • Sub-Investigator: Ja Min Byun
  • Jeonlabuk-do
    • Jeonju, Jeonlabuk-do, South Korea
      • Not yet recruiting
      • Jeonbuk National University Hopital
      • Contact: Ho Young Yhim
      • Principal Investigator: Jae Yong Kwak
      • Sub-Investigator: Ho Young Yhim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with malignant hematologic diseases who are eligible for allogeneic hematopoietic stem cell transplantation

Description

Inclusion Criteria:

• Aged 19 and older
• Patients scheduled for umbilical cord blood transplantation as a primary allogeneic hematopoietic stem cell transplantation for the treatment of the following hematologic diseases:

Acute leukemia (myeloid/lymphoid/mixed lineage) / Myelodysplastic syndromes / Chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms / Malignant lymphomas, multiple myeloma / Other malignant hematologic malignancies / bone marrow failure diseases, including aplastic anemia

- If all contents of the consent form are understood and consented to in writing.

Exclusion Criteria:

• Patients with a history of allogeneic hematopoietic stem cell transplantation or those undergoing transplantation for the treatment of engraftment failure (secondary allogeneic hematopoietic stem cell transplantation is an exclusion criterion; however, patients eligible for registration include those undergoing their first allogeneic stem cell transplantation following an autologous stem cell transplantation).
• Patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator.
• Patients with an ECOG Performance Status (PS) greater than 3 or those receiving mechanical ventilation in the intensive care unit.
• Patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with hematologic disease who will receive double unit cord blood tranplant	Procedure: tranplant; double unit cord blood transplnat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival	2 years
engraftment	Frequency of engraftment	30 days
GVHD	acute and chronic GVHD	2 years
Relapse	Relapse rate	2 years
TRM	Treatment related mortality	3 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Dong-Yeop Shin, MD, PhD., Seoul National University Hospital; Study Director: Sung-Soo Yoon, MD, PhD., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PRODUCT-K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No