NCT00228631

Brief Summary

In this study, patient blood samples from NMA transplants will be provided by Pittsburgh, and samples from myeloablative transplants will be provided by Atlanta (comparative controls). Samples would be obtained pre- and post-BMT from the recipient at a total of 7 timepoints, and from the donor at one timepoint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

5.9 years

First QC Date

September 27, 2005

Last Update Submit

May 23, 2014

Conditions

Sickle Cell Disease

Keywords

sicklecell

Outcome Measures

Primary Outcomes (1)

  • To determine the rate of T cell immune reconstitution in children with sickle cell disease

    1 year after accrual closed

Study Arms (1)

Sickle Cell Disease Bone Marrow Transplant

Sickle Cell Disease Bone Marrow Transplant candidates

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

At in-patient or out-patient transplant clinic (All sickle cell disease bone marrow transplant patients will be offered participation)

You may qualify if:

  • Undergoing allogeneic bone marrow transplantation for sickle cell disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ann Haight, MD

    Children's Healthcare of Atlanta/Emory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Primary Completion

August 1, 2011

Study Completion

July 1, 2012

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)