Clinical trial NCT03689907: Early Chimerism Following Allogeneic Stem-Cell Transplant
Official title: Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allogeneic Stem-Cell Transplant
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants in this study will receive an allogeneic stem-cell transplant.

Brief summary: Allogeneic stem cell transplant (allo-SCT) is a common treatment for variety of blood cancers. To determine how many cells are from the donor after transplant, doctors complete a "chimerism analysis" or a test of participant cells to look at the DNA. Chimerism testing helps doctors predict graft rejection or recurrence of disease. Doctors at NCCC do chimerism testing routinely and it is usually done between 30 and 100 days after transplantation. The researchers believe that analyzing chimerism sooner than 30 days after transplant may help identify problems earlier, get patients treatment sooner, and increase the chances of a successful transplant.

The purpose of this study is to find out if doing chimerism testing earlier than the traditional approach is better for patient outcomes (about 14 days after transplantation rather than 30+ days). Information gained from this study can be used to help prevent some post-transplant complications such as graft loss, graft-versus-host disease, or even relapse for future patients.

Also, the researchers hope to learn more about chimerism testing of cells of patients with haploidentical donors (donors who are only a "half-match" - such as a parent or child of the recipient), because there have not been many chimerism analysis studies done in this population.


Eligibility criteria: Inclusion Criteria:

* All patients will have been cleared by a Transplant Attending to undergo allogeneic stem cell transplant

Exclusion Criteria:

* Patients undergoing a second allogeneic stem cell transplant or beyond

Primary outcomes:
measure: Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients
timeFrame: 14 or 15 days post-transplant
Secondary outcomes:
measure: Correlate early chimersim profiles with donor chimerism
timeFrame: Day +30-post transplant
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: John M. Hill, MD
role: PRINCIPAL_INVESTIGATOR
References:
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