NCT00270881

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

December 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2005

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

3 years

First QC Date

December 28, 2005

Last Update Submit

April 5, 2012

Conditions

Acute Myelogenous LeukemiaAcute Lymphoblastic LeukemiaChronic Myelogenous LeukemiaMyelodysplastic Syndrome

Keywords

cord blood transplantationmyeloablative regimenhematologic malignancies

Outcome Measures

Primary Outcomes (1)

  • Non-relapse mortality at 1 year

    1 year

Secondary Outcomes (7)

  • Engraftment

    day 56

  • Disease free survival

    1 year

  • Overall survival

    1 year

  • Incidence of acute and chronic graft-versus-host disease

    day100 and 1 year

  • Incidence of infectious complication

    1year

  • +2 more secondary outcomes

Interventions

Cord blood transplantationPROCEDURE

unrelated cord blood transplantation

TBIRADIATION

Total body irradiation (TBI) 12Gy

cyclophosphamideDRUG

cyclophosphamide 120mg/kg

cytarabineDRUG

cytarabine 3g/m2x4

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
  • Lack of HLA-identical or 1 locus mismatched related donor
  • Age over 20, and under 55
  • Performance status 0 or 1
  • No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
  • No anti-HLA antibody
  • Informed consent was obtained

You may not qualify if:

  • Uncontrollable diabetes
  • Uncontrollable hypertension
  • Active infection
  • TPHA, HBs-Ag, HCV-Ab positive
  • HTLV-I, HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keio University School of Medicine

Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic SyndromesHematologic Neoplasms

Interventions

Cord Blood Stem Cell TransplantationCyclophosphamideCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Hisashi Sakamaki, M.D., Ph.D.

    Tokyo Metropolitan Komagome Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 28, 2005

First Posted

December 29, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

JP(1)