Clinical trial NCT06712108: Observational Study of Double Cord Blood Transplant
Official title: PROspective Multicenter Observational Study of Double Unit Umbilical Cord Lood Transplantation in Korean Adult Patients with Hematologic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Double Unit Cord Blood Transplant
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with malignant hematologic diseases who are eligible for allogeneic hematopoietic stem cell transplantation

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


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: engraftment
timeFrame: 30 days
measure: GVHD
timeFrame: 2 years
measure: PFS
timeFrame: 2 years
measure: TRM
timeFrame: 3mo
measure: Relapse
timeFrame: 2 years
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hopital
state: Jeonlabuk-do
city: Daegu
country: Korea, Republic of
facility: Keimyung Unversity Dongsan Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Dong-Yeop Shin, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Sung-Soo Yoon, MD, PhD.
role: STUDY_DIRECTOR
References: