Observing the effects of double cord blood transplants in adults
PROspective Multicenter Observational Study of Double Unit Umbilical Cord Lood Transplantation in Korean Adult Patients With Hematologic Diseases.
This study is testing how well double cord blood transplants work for adults with blood cancers and whether different types of pre-treatment are safe and effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 6 sites (Jeonju, Jeonlabuk-do and 5 other locations) |
| Trial ID | NCT06712108 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of both non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation in adult patients with malignant hematologic diseases. The study focuses on patients who are eligible for allogeneic hematopoietic stem cell transplantation and collects clinical data to analyze outcomes. By observing real-world applications of this treatment, the study aims to provide insights into its effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older scheduled for umbilical cord blood transplantation for various hematologic malignancies.
Not a fit: Patients with a history of allogeneic hematopoietic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for adults with malignant hematologic diseases requiring stem cell transplantation.
How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jeonju, Jeonlabuk-do and 5 other locations
- Jeonbuk National University Hopital — Jeonju, Jeonlabuk-do, South Korea (Not_yet_recruiting)
- Keimyung Unversity Dongsan Hospital — Daegu, South Korea (Not_yet_recruiting)
- Dong-A University Hospital — Pusan, South Korea (Not_yet_recruiting)
- Pusan National University Hospital — Pusan, South Korea (Not_yet_recruiting)
- Seoul National University Bundang Hospital — Seongnam, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Dong-Yeop Shin, MD, PhD. — Seoul National University Hospital
- Study coordinator: Dong-Yeop Shin, MD, PhD.
- Email: shindongyeop@snu.ac.kr
- Phone: +82-2-2072-7209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.