NCT01141959

Brief Summary

The investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. We will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 31, 2023

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

June 8, 2010

Last Update Submit

May 30, 2023

Conditions

LeukemiaHodgkin DiseaseNon-Hodgkin LymphomaMyelodysplastic SyndromeMultiple Myeloma

Keywords

hematopoietic stem cell transplantationcyclophosphamidefludarabinemycophenolate mofetilmycophenolic acidbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Donor T-cell chimerism

    Day 28 post-transplant

Secondary Outcomes (1)

  • Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products

    1 week before through 3 weeks after transplant

Eligibility Criteria

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

Hematopoeitic cell transplant patients with haploidentical donors receiving cyclophosphamide, fludarabine and mycophenolate mofetil.

You may qualify if:

  • Scheduled to receive nonmyeloablative conditioning which includes fludarabine
  • Scheduled to receive a haploidentical graft
  • Scheduled to receive postgrafting immunosuppression which includes oral mycophenolate mofetil (MMF) or enteric-coated mycophenolic acid
  • Age \>18 years at the time of enrollment

You may not qualify if:

  • Diagnosed with an immunodeficiency disorder, including HIV

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 SyndromesMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Jeannine McCune, PharmD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 11, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 31, 2023

Record last verified: 2015-03

Locations

US(1)