NCT02385955

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

January 20, 2015

Last Update Submit

March 10, 2015

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    2 years

Secondary Outcomes (7)

  • Progression-free survival

    2 years

  • Time to relapse or progression

    2 years

  • Time to engraftment

    2 years

  • Acute graft-versus-host disease

    2 years

  • Chronic graft-versus-host disease

    2 years

  • +2 more secondary outcomes

Study Arms (1)

Myeloablative dUCBT

EXPERIMENTAL

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

Interventions

Myeloablative double unit cord blood transplantationPROCEDURE

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).

Myeloablative dUCBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 17038536BACKGROUND

  • 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.

    PMID: 23253560BACKGROUND

  • 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.

    PMID: 22327127BACKGROUND

  • 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.

    PMID: 24005245BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Sung-Soo Yoon, MD, PhD

CONTACT

+82-2-2072-3079ssysmc@snu.ac.kr

Junglim Lee, MD

CONTACT

+82-53-940-7450junglim3@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2015

First Posted

March 11, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2019

Last Updated

March 11, 2015

Record last verified: 2015-03