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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06712108

Enrollment

Registered

2024-12-02

Start date

2023-12-21

Completion date

2030-03-31

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Double Unit Cord Blood Transplant

Brief summary

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

Interventions

PROCEDUREtranplant

double unit cord blood transplnat

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall Survival	2 years

Secondary

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

Countries

South Korea

Contacts

CONTACTDong-Yeop Shin, MD, PhD.

shindongyeop@snu.ac.kr+82-2-2072-7209

PRINCIPAL_INVESTIGATORDong-Yeop Shin, MD, PhD.

Seoul National University Hospital

STUDY_DIRECTORSung-Soo Yoon, MD, PhD.