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NCT Number: NCT06712108

Double Unit Cord Blood Transplant in Hematologic Malignancies.

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

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jeonbuk National University Hopital, Jeonju, Jeonlabuk-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tranplant

Procedure

double unit cord blood transplnat

Primary outcomes

  1. Overall Survival

    Time frame: 2 years

Secondary outcomes

  1. engraftment

    Time frame: 30 days

    Frequency of engraftment

  2. GVHD

    Time frame: 2 years

    acute and chronic GVHD

  3. PFS

    Time frame: 2 years

    Progression-free survival

  4. TRM

    Time frame: 3 months

    Treatment related mortality

  5. Relapse

    Time frame: 2 years

    Relapse rate

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Yeop Shin, MD, PhD.

CONTACT

[email protected]

+82-2-2072-7209

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Dec 2, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.