NCT00764829

Brief Summary

We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

3.4 years

First QC Date

September 30, 2008

Last Update Submit

February 13, 2012

Conditions

LeukemiaHodgkins DiseaseNon-hodgkins LymphomaMyelodysplastic Syndrome

Keywords

hematopoietic stem cell transplantationfludarabinemycophenolate mofetilmycophenolic acidbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Donor T-cell chimerism

    Day 28 post-transplant

Secondary Outcomes (1)

  • Exposure to fludarabine and mycophenolate mofetil and their breakdown products.

    Before and after transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.

You may qualify if:

  • Diagnosed with a hematologic disease or malignancy
  • Scheduled to receive nonablative conditioning with fludarabine and total body irradiation
  • Donor is well-matched by high resolution DNA techniques.
  • Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.
  • Age \>18 years at the time of enrollment.

You may not qualify if:

  • Diagnosed with an immunodeficiency disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma,DNA

MeSH Terms

Conditions

LeukemiaHodgkin DiseaseLymphoma, Non-HodgkinMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow Diseases

Study Officials

  • Jeannine S McCune, PharmD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

US(1)