Observational Study of Double Cord Blood Transplant

NCT ID: NCT06712108

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-21

Study Completion Date

2030-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Adult Double Unit Cord Blood Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with hematologic disease who will receive double unit cord blood tranplant

tranplant

Intervention Type PROCEDURE

double unit cord blood transplnat

Interventions

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tranplant

double unit cord blood transplnat

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* (1) Aged 19 and older (2) 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) planned for transplantation for treatment purposes

* Myelodysplastic syndromes planned for transplantation for treatment purposes ③ Chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms planned for transplantation for treatment purposes ④ Malignant lymphomas, multiple myeloma planned for transplantation for treatment purposes ⑤ Other malignant hematologic malignancies planned for transplantation for treatment purposes ⑥ Planned for transplantation for the treatment of bone marrow failure diseases, including aplastic anemia (3) If all contents of the consent form are understood and consented to in writing.

Exclusion Criteria

* (1) 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).

(2) Patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator.

(3) Patients with an ECOG Performance Status (PS) greater than 3 or those receiving mechanical ventilation in the intensive care unit.

(4) Patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Yeop Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Yeop Shin, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Sung-Soo Yoon, MD, PhD.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Jeonbuk National University Hopital

Jeonju, Jeonlabuk-do, South Korea

Site Status NOT_YET_RECRUITING

Keimyung Unversity Dongsan Hospital

Daegu, , South Korea

Site Status NOT_YET_RECRUITING

Dong-A University Hospital

Pusan, , South Korea

Site Status NOT_YET_RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong-Yeop Shin, MD, PhD.

Role: CONTACT

+82-2-2072-7209

Facility Contacts

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Ho Young Yhim

Role: primary

Jae Yong Kwak

Role: backup

Young Rok Do

Role: primary

Sung Hyun Kim

Role: primary

Ji Hyun Lee

Role: backup

Do Young Kim

Role: primary

Ho Jin Shin

Role: backup

Soo Mee Bang

Role: primary

Jeong Ok Lee

Role: backup

Dong-Yeop Shin, MD, PhD

Role: primary

Eunhee Park, RN

Role: backup

Dong-Yeop Shin

Role: backup

Sung-Soo Yoon

Role: backup

Junshik Hong

Role: backup

Ja Min Byun

Role: backup

Other Identifiers

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PRODUCT-K

Identifier Type: -

Identifier Source: org_study_id