Observational Study of Double Cord Blood Transplant

Recruiting

• Conditions: Adult Double Unit Cord Blood Transplant

• Registration Number: NCT06712108
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	2 years

Secondary Outcome Measures

Name	Time	Method
engraftment	30 days	Frequency of engraftment
GVHD	2 years	acute and chronic GVHD
PFS	2 years	Progression-free survival
TRM	3mo	Treatment related mortality
Relapse	2 years	Relapse rate

Trial Locations

Locations (6)

Jeonbuk National University Hopital; 🇰🇷 Jeonju, Jeonlabuk-do, Korea, Republic of

Keimyung Unversity Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Pusan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of