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Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

Primary Purpose

Hematologic Malignancy

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Myeloablative double unit cord blood transplantation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
  • Patients who have suitable cord blood units for dUCBT
  • Patients with ECOG performance status 0-1
  • Patients with adequate organ function: lung, kidney, liver, heart, etc.
  • Informed consent

Exclusion Criteria:

  • Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
  • Patients who have anti-HLA antibodies
  • Patients with any evidence of central nervous system (CNS) involvement of disease
  • Patients with uncontrolled diabetes
  • Patients with uncontrolled hypertension
  • Patients with any evidence of active infection
  • Positive for human immunodeficiency virus (HIV)
  • Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.)
  • Women who are pregnant or breastfeeding
  • Patients with previous history of allogeneic stem cell transplantation
  • Patients with major psychotic disorder or drug/alcohol abuser
  • Inappropriate patients according to the investigators' opinion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Myeloablative dUCBT

    Arm Description

    Myeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant

    Outcomes

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Progression-free survival
    Time to relapse or progression
    Time to engraftment
    Acute graft-versus-host disease
    Chronic graft-versus-host disease
    Non-relapse mortality
    Other transplant-related serious adverse events

    Full Information

    First Posted
    January 20, 2015
    Last Updated
    March 10, 2015
    Sponsor
    Seoul National University Hospital
    Collaborators
    The Korean Society of Blood and Marrow Transplantation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02385955
    Brief Title
    Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients
    Official Title
    Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    April 2017 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    The Korean Society of Blood and Marrow Transplantation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematologic Malignancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Myeloablative dUCBT
    Arm Type
    Experimental
    Arm Description
    Myeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant
    Intervention Type
    Procedure
    Intervention Name(s)
    Myeloablative double unit cord blood transplantation
    Intervention Description
    Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI, 12Gy), followed by cyclophosphamide (60 mg/kg/day on day -3 and -2) and cytarabine (3 g/m2 every 12 hours on day -5 and -4), or (2) thiotepa (5 mg/kg/day on day -7 and -6), busulfan (3.2 mg/kg/day on day -5, -4, and -3), and fludarabine (50 mg/m2/day on day -5, -4, and -3).
    Primary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Time Frame
    2 years
    Title
    Time to relapse or progression
    Time Frame
    2 years
    Title
    Time to engraftment
    Time Frame
    2 years
    Title
    Acute graft-versus-host disease
    Time Frame
    2 years
    Title
    Chronic graft-versus-host disease
    Time Frame
    2 years
    Title
    Non-relapse mortality
    Time Frame
    2 years
    Title
    Other transplant-related serious adverse events
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome Patients who have suitable cord blood units for dUCBT Patients with ECOG performance status 0-1 Patients with adequate organ function: lung, kidney, liver, heart, etc. Informed consent Exclusion Criteria: Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors Patients who have anti-HLA antibodies Patients with any evidence of central nervous system (CNS) involvement of disease Patients with uncontrolled diabetes Patients with uncontrolled hypertension Patients with any evidence of active infection Positive for human immunodeficiency virus (HIV) Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.) Women who are pregnant or breastfeeding Patients with previous history of allogeneic stem cell transplantation Patients with major psychotic disorder or drug/alcohol abuser Inappropriate patients according to the investigators' opinion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sung-Soo Yoon, MD, PhD
    Phone
    +82-2-2072-3079
    Email
    ssysmc@snu.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junglim Lee, MD
    Phone
    +82-53-940-7450
    Email
    junglim3@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17038536
    Citation
    Takahashi S, Ooi J, Tomonari A, Konuma T, Tsukada N, Oiwa-Monna M, Fukuno K, Uchiyama M, Takasugi K, Iseki T, Tojo A, Yamaguchi T, Asano S. Comparative single-institute analysis of cord blood transplantation from unrelated donors with bone marrow or peripheral blood stem-cell transplants from related donors in adult patients with hematologic malignancies after myeloablative conditioning regimen. Blood. 2007 Feb 1;109(3):1322-30. doi: 10.1182/blood-2006-04-020172. Epub 2006 Oct 12.
    Results Reference
    background
    PubMed Identifier
    23253560
    Citation
    Mori T, Tanaka M, Kobayashi T, Ohashi K, Fujisawa S, Yokota A, Fujita H, Nakaseko C, Sakura T, Nannya Y, Takahashi S, Kanamori H, Kanda Y, Sakamaki H, Okamoto S; Kanto Study Group for Cell Therapy. Prospective multicenter study of single-unit cord blood transplantation with myeloablative conditioning for adult patients with high-risk hematologic malignancies. Biol Blood Marrow Transplant. 2013 Mar;19(3):486-91. doi: 10.1016/j.bbmt.2012.12.007. Epub 2012 Dec 16.
    Results Reference
    background
    PubMed Identifier
    22327127
    Citation
    Sanz J, Boluda JC, Martin C, Gonzalez M, Ferra C, Serrano D, de Heredia CD, Barrenetxea C, Martinez AM, Solano C, Sanz MA, Sanz GF; Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular (GETH). Single-unit umbilical cord blood transplantation from unrelated donors in patients with hematological malignancy using busulfan, thiotepa, fludarabine and ATG as myeloablative conditioning regimen. Bone Marrow Transplant. 2012 Oct;47(10):1287-93. doi: 10.1038/bmt.2012.13. Epub 2012 Feb 13.
    Results Reference
    background
    PubMed Identifier
    24005245
    Citation
    Ruggeri A, Sanz G, Bittencourt H, Sanz J, Rambaldi A, Volt F, Yakoub-Agha I, Ribera JM, Mannone L, Sierra J, Mohty M, Solano C, Nabhan S, Arcese W, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of European Blood and Marrow Transplant Group. Comparison of outcomes after single or double cord blood transplantation in adults with acute leukemia using different types of myeloablative conditioning regimen, a retrospective study on behalf of Eurocord and the Acute Leukemia Working Party of EBMT. Leukemia. 2014 Apr;28(4):779-86. doi: 10.1038/leu.2013.259. Epub 2013 Sep 5.
    Results Reference
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    Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

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