Stem Cell Related Donor Safety Study (RDSafe)

A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life

The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors.

The study will also assess the hypothesis that young (<18 years) and older (>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations.

An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.

Study Overview

• Status: Completed
• Conditions: Related Hematopoietic Stem Cell Donors

• Study Type: Observational
• Enrollment (Actual): 1812

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Medical Center
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Orlando, Florida, United States, 32804
      • Florida Center for Cellular Therapy
    • Saint Petersburg, Florida, United States, 33701
      • All Children's Hospital
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60014
      • Children's Memorial Medical Center
  • Indiana
    • Beech Grove, Indiana, United States, 46107
      • Indiana Blood and Marrow Transplantation, LLC
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • Umass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical Center
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Center
    • Grand Rapids, Michigan, United States, 49503
      • Helen DeVos Children's Hospital - Spectrum Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Rochester
  • Mississippi
    • Jackson, Mississippi, United States, 39095
      • University of Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center - Hackensack University Medcial Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Lake Success, New York, United States, 11042
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center of NY
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mt. Sinai Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Jewish Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland/Case Western
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • San Antonio, Texas, United States, 78229
      • Texas Institute of Medicine and Surgery
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah, Primary Children's Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

participating institutions (transplant centers)

Description

Inclusion Criteria:

• Donors of any age providing either a first or second BM or PBSC donation
• Meet donation criteria per institution policies and procedures
• Willing to receive phone follow-up at 1, 6, and 12 months
• Signed informed consent for study participation

For the HRQoL ancillary study, inclusion criteria:

• Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria
• Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview
• English speaking
• Access to a telephone
• Willing to participate in pre-donation, 1 month and 1 year follow-up interviews
• Signed informed consent for study participation in ancillary study

Exclusion Criteria:

• Per institutional guidelines
• Donors providing unstimulated peripheral blood stem cells or lymphocytes

For the HRQoL ancillary study, exclusion criteria:

• Children less than or equal to 4 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Related Donors; Related Hematopoietic Stem Cell Donors

Collaborators and Investigators

• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: University of Pittsburgh; National Institutes of Health (NIH); University of Utah
• Investigators: Principal Investigator: Michael A Pulsipher, M.D., Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 28, 2009
• First Submitted That Met QC Criteria: July 28, 2009
• First Posted (Estimate): July 29, 2009

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 06-DON