Details

Details

Title (Adult/Pediatric) A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life.

IRB CBMT 1Z09

CC CC956

Hospital Main Campus

Stage N/A

Phase N/A

Disease Blood & Marrow Transplant (BMT), Hematologic Malignancy

Description

Description

  1. Primary Objectives:
    • Compare the incidence of serious and severe adverse events in related hematopoietic stem cell (HSC) donors in Age Group 1 (ages 18-40) and Age Group 2 (ages 41-60) versus a comparative cohort of unrelated donors within the same respective age groups.
    • Describe the incidence of serious and severe adverse events in related BM and PBSC donors ages < 18 and > 60.
  2. Secondary Objectives:
    • Describe the incidence of vascular complications, hematologic malignancies, splenic rupture, and new onset or flares of autoimmune illnesses within twelve months of donation in RDs and URDs treated with and without filgrastim prior to donation.
    • Compare clinical and demographic characteristics of related and unrelated HSC donors by age groups.
    • Correlate the type and number of pre-donation risk factors of RDs with toxicities measured in Primary Objectives 1 and 2 and Secondary Objective 1.
  3. Ancillary Study Objectives:
    • Compare the HRQoL of related donors ages 18-60 to that of unrelated HSC donors ages 18-60, as defined by the SF-36 tool.
    • Compare HRQoL of related pediatric (ages 5-17), as defined by the PedsQL 4.0 tool, and adult (ages 18-60), and older-adult (age > 60) HSC donors as defined by the SF-36 tool, with that of age-matched healthy normative cohorts.
    • Compare the donation-related HRQoL experience as defined by the SF-36, of related and unrelated adult (ages 18 - 60) HSC donors from pre-donation through one year follow-up.
    • Examine the effect of pre-donation psychosocial variables on post-donation HRQoL as defined by the PedsQL 4.0 in the pediatric cohort and the SF-36 in adult and older-adult cohorts.
    • Compare the donation-related HRQoL experience between BM and PBSC donors.
    • Describe the donation-related HRQoL experience of filgrastim-primed BM donors.
Inclusion Criteria

Inclusion Criteria

  1. Donor Inclusion Criteria
    • Donors of any age providing either a first or second BM or PBSC donation (see Section 4.1.1 for details).
    • Meet donation criteria per institution policies and procedures
    • Willing to receive phone follow-up from NMDP research staff at 1, 6 and 12 months
    • Signed informed consent for study participation
  2. HRQoL Inclusion Criteria
    • Related donors age ≥ 5, eligible and consented to the primary trial by the inclusion criteria listed in section 2.3 above. Donors may choose to only participate in the medical toxicity portion of the study (i.e., not participate in the HRQoL ancillary study).
    • Donors should be competent to answer the psychological assessment questions by themselves (adult cohorts). For the pediatric cohort (ages 5-17), the child donor should be willing/able to respond to psychological assessment questions and have an appropriate proxy (i.e. parent/guardian) also willing/able to complete the HRQoL proxy interview.
    • English speaking.
    • Access to a telephone for interviews.
    • Willing to participate, if chosen, in pre-donation, one month and one year follow-up interviews.
    • Signed informed consent for study participation in the HRQoL ancillary study.
Exclusion Criteria

Exclusion Criteria

  1. Donor Exclusion Criteria
    • Donor exclusion criteria per institutional guidelines.
    • Donors providing unstimulated peripheral blood stem cells or lymphocytes (i.e. donor lymphocyte infusion or boost) are not eligible
  2. HRQoL Inclusion Criteria
    • Children ≤ 4 years of age are excluded.