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

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ClinicalTrials.gov Identifier: NCT02385955
Recruitment Status : Not yet recruiting
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
The Korean Society of Blood and Marrow Transplantation
Information provided by (Responsible Party):
Sung-Soo Yoon, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Procedure: Myeloablative double unit cord blood transplantation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Myeloablative dUCBT
Myeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant
Procedure: Myeloablative double unit cord blood transplantation
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 Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
  2. Time to relapse or progression [ Time Frame: 2 years ]
  3. Time to engraftment [ Time Frame: 2 years ]
  4. Acute graft-versus-host disease [ Time Frame: 2 years ]
  5. Chronic graft-versus-host disease [ Time Frame: 2 years ]
  6. Non-relapse mortality [ Time Frame: 2 years ]
  7. Other transplant-related serious adverse events [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385955


Contacts
Contact: Sung-Soo Yoon, MD, PhD +82-2-2072-3079 ssysmc@snu.ac.kr
Contact: Junglim Lee, MD +82-53-940-7450 junglim3@gmail.com

Sponsors and Collaborators
Seoul National University Hospital
The Korean Society of Blood and Marrow Transplantation

Publications:

Responsible Party: Sung-Soo Yoon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02385955     History of Changes
Other Study ID Numbers: KSBMT200809
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Neoplasms