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Early Chimerism Following Allogeneic Stem-Cell Transplant

Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03689907
Enrollment
40
Registered
2018-10-01
Start date
2019-12-19
Completion date
2024-12-30
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

OTHERChimerism Evaluation

Blood collection for chimerism evaluation will be performed on days +14/15-post transplant and +30-post transplant for each study participant.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients14 or 15 days post-transplantOur method of chimerism analysis is dependent on baseline DNA samples of pre-transplant donor and recipient, then serial assessment of polymorphic short tandem repeats (STRs) to specifically characterize the source (donor vs recipient) of DNA extracted from our patients' leukocytes at day +14/15 after allogeneic stem cell transplant. First, DNA is extracted from the buffy coat layer of an EDTA blood sample, then PCR reactions using STR markers are prepared, and the differently sized fluorescent PCR products are then assessed on a genetic analyzer. An assessment of the relative amounts of donor and recipient chimerism can then be determined from the analyzer output, based on peak height and area. The discreet leukocyte lineages are then isolated by cell separation, and DNA is isolated from these purified fractions and assessed as for whole blood.

Secondary

MeasureTime frameDescription
Correlate early chimersim profiles with donor chimerismDay +30-post transplantDay +14/15-post transplant absolute neutrophil count and absolute lymphocyte count will be compared to the Day +30-post transplant lineage-specific chimerism profile to determine if there is a correlation between early lineage chimerism and full donor chimerism.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026