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

March 10, 2015 updated by: Sung-Soo Yoon, Seoul National University Hospital

Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sung-Soo Yoon, MD, PhD
  • Phone Number: +82-2-2072-3079
  • Email: ssysmc@snu.ac.kr

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 years
2 years
Non-relapse mortality
Time Frame: 2 years
2 years
Time to relapse or progression
Time Frame: 2 years
2 years
Time to engraftment
Time Frame: 2 years
2 years
Acute graft-versus-host disease
Time Frame: 2 years
2 years
Chronic graft-versus-host disease
Time Frame: 2 years
2 years
Other transplant-related serious adverse events
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

The Korean Society of Blood and Marrow Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSBMT200809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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