NCT00212407

Brief Summary

Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4,476

participants targeted

Target at P75+ for early_phase_1 leukemia

Timeline
Completed

Started Feb 1993

Longer than P75 for early_phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

February 1, 1993

Completed
12.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2011

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

18.8 years

First QC Date

September 13, 2005

Last Update Submit

October 31, 2018

Conditions

LeukemiaLymphomaGenetic DiseaseSevere Aplastic AnemiaMyelodysplasia

Keywords

Cord blood transplantationbone marrow transplantation

Outcome Measures

Primary Outcomes (3)

  • Engraftment

    released prior to 12-1-2012

  • Treatment Related Mortality

    released prior to 12-1-2012

  • Survival

    released prior to 12-1-2012

Secondary Outcomes (2)

  • Graft vs. Host Disease

    released prior to 12-1-2012

  • Relapse

    released prior to 12-1-2012

Study Arms (1)

Umbilical cord blood unit(s) transplant

EXPERIMENTAL

Transplantation of cryopreserved umbilical cord blood unit(s)

Biological: Umbilical Cord Blood Transplantation

Interventions

Umbilical Cord Blood TransplantationBIOLOGICAL
Also known as: One or more matched umbilical cord blood units for transplant
Umbilical cord blood unit(s) transplant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for bone marrow transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Blood Center

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaGenetic Diseases, InbornAnemia, AplasticAnemia, Refractory, with Excess of Blasts

Interventions

Cord Blood Stem Cell TransplantationTransplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemiaBone Marrow Failure DisordersBone Marrow DiseasesAnemia, RefractoryMyelodysplastic Syndromes

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Pablo Rubinstein, M.D.

    New York Blood Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 1993

Primary Completion

November 10, 2011

Study Completion

November 10, 2011

Last Updated

November 2, 2018

Record last verified: 2018-10

Locations

US(1)