Allogeneic Stem-Cell Transplant Clinical Trial
Official title:
Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant
| NCT number | NCT03689907 |
| Other study ID # | D18125 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 19, 2019 |
| Est. completion date | January 2025 |
Allogeneic stem cell transplant (allo-SCT) is a common treatment for variety of blood cancers. To determine how much of your cells are from your donor after transplant, doctors complete a "chimerism analysis" or a test of your 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). We hope the 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
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | January 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center | Lebanon | New Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| Dartmouth-Hitchcock Medical Center |
United States,
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* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients | Our 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. | 14 or 15 days post-transplant | |
| Secondary | Correlate early chimersim profiles with donor chimerism | Day +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. | Day +30-post transplant |