Observational Study of Double Cord Blood Transplant

Last updated: November 26, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

tranplant

Clinical Study ID

NCT06712108
PRODUCT-K
  • Ages > 19
  • All Genders

Study 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

Inclusion Criteria:

  • (1) Aged 19 and older (2) Patients scheduled for umbilical cord bloodtransplantation as a primary allogeneic hematopoietic stem cell transplantation forthe treatment of the following hematologic diseases:

  • Acute leukemia (myeloid/lymphoid/mixed lineage) planned for transplantation fortreatment purposes

  • Myelodysplastic syndromes planned for transplantation for treatmentpurposes ③ Chronic leukemia (myeloid/lymphoid/monocytic) andmyeloproliferative neoplasms planned for transplantation for treatmentpurposes ④ Malignant lymphomas, multiple myeloma planned fortransplantation for treatment purposes ⑤ Other malignant hematologicmalignancies planned for transplantation for treatment purposes ⑥ Plannedfor transplantation for the treatment of bone marrow failure diseases,including aplastic anemia (3) If all contents of the consent form areunderstood and consented to in writing.

Exclusion

Exclusion Criteria:

  • (1) Patients with a history of allogeneic hematopoietic stem cell transplantation orthose undergoing transplantation for the treatment of engraftment failure (secondaryallogeneic hematopoietic stem cell transplantation is an exclusion criterion;however, patients eligible for registration include those undergoing their firstallogeneic stem cell transplantation following an autologous stem celltransplantation).

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

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

(4) Patients who do not consent to participate in the study or those deemedunsuitable for sincere participation by the attending physician.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: tranplant
Phase:
Study Start date:
December 21, 2023
Estimated Completion Date:
March 31, 2030

Connect with a study center

  • Jeonbuk National University Hopital

    Jeonju, Jeonlabuk-do
    Korea, Republic of

    Site Not Available

  • Keimyung Unversity Dongsan Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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