Allogeneic Stem-Cell TransplantNCT03689907
Early Chimerism Following Allogeneic Stem-Cell Transplant
An observational study of Allogeneic Stem-Cell Transplant, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Stem-Cell Transplant
- What is being tested?
- Chimerism Evaluation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants in this study will receive an allogeneic stem-cell transplant.
Who may be able to join
- All patients will have been cleared by a Transplant Attending to undergo allogeneic stem cell transplant
Who cannot join
- Patients undergoing a second allogeneic stem cell transplant or beyond
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
About this study
Official title: Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant
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.
- Conditions
- Allogeneic Stem-Cell Transplant
- Being tested
- Chimerism Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimerism EvaluationOther
Blood collection for chimerism evaluation will be performed on days +14/15-post transplant and +30-post transplant for each study participant.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Stem-Cell Transplant Recipients | 1. At day +14/15-post transplant - lineage-specific chimerism analysis will be performed on a peripheral blood sample drawn from the patient.
2. At day +30-post transplant, most participants will be in the outpatient setting and would undergo chimerism evaluation as part of the standard of care for transplant patients. Receives: Other: Chimerism Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 or 15 days post-transplant
Secondary outcomes (1)
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.
Measured: Day +30-post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start19 Dec 2019
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Stem-Cell TransplantStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Hill, Jr., MD, Dartmouth-Hitchcock Medical Center
- Investigators
- John M. Hill, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689907
- Sponsor's protocol ID
- D18125
- Other IDs
- NCI-2020-03008
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2018
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farhan S, Bazydlo M, Neme K, Mikulandric N, Peres E, Janakiraman N. Chimerism in Myeloid Malignancies following Stem Cell Transplantation Using FluBu4 with and without Busulfan Pharmacokinetics versus BuCy. Adv Hematol. 2017;2017:8690416. doi: 10.1155/2017/8690416. Epub 2017 Nov 8.
PubMed 29250116Passweg JR, Baldomero H, Bader P, Bonini C, Duarte RF, Dufour C, Gennery A, Kroger N, Kuball J, Lanza F, Montoto S, Nagler A, Snowden JA, Styczynski J, Mohty M. Use of haploidentical stem cell transplantation continues to increase: the 2015 European Society for Blood and Marrow Transplant activity survey report. Bone Marrow Transplant. 2017 Jun;52(6):811-817. doi: 10.1038/bmt.2017.34. Epub 2017 Mar 13.
PubMed 28287639Parmesar K, Raj K. Haploidentical Stem Cell Transplantation in Adult Haematological Malignancies. Adv Hematol. 2016;2016:3905907. doi: 10.1155/2016/3905907. Epub 2016 May 30.
PubMed 27313619Fabricius WA, Ramanathan M. Review on Haploidentical Hematopoietic Cell Transplantation in Patients with Hematologic Malignancies. Adv Hematol. 2016;2016:5726132. doi: 10.1155/2016/5726132. Epub 2016 Feb 29.
PubMed 27034676Bashey A, Solomon SR. T-cell replete haploidentical donor transplantation using post-transplant CY: an emerging standard-of-care option for patients who lack an HLA-identical sibling donor. Bone Marrow Transplant. 2014 Aug;49(8):999-1008. doi: 10.1038/bmt.2014.62. Epub 2014 May 19.
PubMed 24842530Koreth J, Kim HT, Nikiforow S, Milford EL, Armand P, Cutler C, Glotzbecker B, Ho VT, Antin JH, Soiffer RJ, Ritz J, Alyea EP 3rd. Donor chimerism early after reduced-intensity conditioning hematopoietic stem cell transplantation predicts relapse and survival. Biol Blood Marrow Transplant. 2014 Oct;20(10):1516-21. doi: 10.1016/j.bbmt.2014.05.025. Epub 2014 Jun 4.
PubMed 24907627Reshef R, Hexner EO, Loren AW, Frey NV, Stadtmauer EA, Luger SM, Mangan JK, Gill SI, Vassilev P, Lafferty KA, Smith J, Van Deerlin VM, Mick R, Porter DL. Early donor chimerism levels predict relapse and survival after allogeneic stem cell transplantation with reduced-intensity conditioning. Biol Blood Marrow Transplant. 2014 Nov;20(11):1758-66. doi: 10.1016/j.bbmt.2014.07.003. Epub 2014 Jul 10.
PubMed 25016197Mathur, A and Malhotra, H. Haploidentical Stem Cell Transplantation: A Mini Review. J Stem Cell Res Ther 2017; 2(2): 00056.
Mattsson J, Ringden O, Storb R. Graft failure after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2008 Jan;14(1 Suppl 1):165-70. doi: 10.1016/j.bbmt.2007.10.025.
PubMed 18162238Legrand, F et al. Chimerism Analysis after Haploidentical Stem Cell Transplantation: Is It Necessary for All Patients? Blood 2016; 128: 3417.
Hussain, A et al. Lineage-Specific Chimerism and Incidence of Graft Failure Following T-Cell Replete Haploidentical Transplantation Using Post-Transplant Cyclophosphamide in Eighty-Nine Consecutive Patients From a Single Center. Blood 2012; 120: 3030.
Moscardo F, Sanz J, Senent L, Cantero S, de la Rubia J, Montesinos P, Planelles D, Lorenzo I, Cervera J, Palau J, Sanz MA, Sanz GF. Impact of hematopoietic chimerism at day +14 on engraftment after unrelated donor umbilical cord blood transplantation for hematologic malignancies. Haematologica. 2009 Jun;94(6):827-32. doi: 10.3324/haematol.2008.000935.
PubMed 19483157Miura Y, Tanaka J, Toubai T, Tsutsumi Y, Kato N, Hirate D, Kaji M, Sugita J, Shigematsu A, Iwao N, Ota S, Masauzi N, Fukuhara T, Kasai M, Asaka M, Imamura M. Analysis of donor-type chimerism in lineage-specific cell populations after allogeneic myeloablative and non-myeloablative stem cell transplantation. Bone Marrow Transplant. 2006 May;37(9):837-43. doi: 10.1038/sj.bmt.1705352.
PubMed 16547484Breuer S, Preuner S, Fritsch G, Daxberger H, Koenig M, Poetschger U, Lawitschka A, Peters C, Mann G, Lion T, Matthes-Martin S. Early recipient chimerism testing in the T- and NK-cell lineages for risk assessment of graft rejection in pediatric patients undergoing allogeneic stem cell transplantation. Leukemia. 2012 Mar;26(3):509-19. doi: 10.1038/leu.2011.244. Epub 2011 Sep 16.
PubMed 21926962Choi, YB et al. Does Day 14 Peripheral Blood Chimerism after Allogeneic Hematopoietic Stem Cell Transplantation Predict Treatment Failure in Children with Non-Malignant Disease? BBMT 2016; 22: S310.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant
- ClinicalTrials.gov ID
- NCT03689907
- Acronym / sponsor ID
- D18125
- Conditions
- Allogeneic Stem-Cell Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Stem-Cell Transplant Recipients | – | Other: Chimerism Evaluation1. At day +14/15-post transplant - lineage-specific chimerism analysis will be performed on a peripheral blood sample drawn from the patient. 2. At day +30-post transplant, most participants will be in the outpatient setting and would undergo chimerism evaluation as part of the standard of care for transplant patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants in this study will receive an allogeneic stem-cell transplant.
Key inclusion criteria (1 listed)
- All patients will have been cleared by a Transplant Attending to undergo allogeneic stem cell transplant
Key exclusion criteria (1 listed)
- Patients undergoing a second allogeneic stem cell transplant or beyond
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimerism EvaluationBlood collection for chimerism evaluation will be performed on days +14/15-post transplant and +30-post transplant for each study participant. | Other | Allogeneic Stem-Cell Transplant Recipients |
Primary outcome
Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients
Time frame: 14 or 15 days post-transplant
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.
1 secondary outcome
Correlate early chimersim profiles with donor chimerism
Time frame: Day +30-post transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 29250116Farhan S, Bazydlo M, Neme K, Mikulandric N, Peres E, Janakiraman N. Chimerism in Myeloid Malignancies following Stem Cell Transplantation Using FluBu4 with and without Busulfan Pharmacokinetics versus BuCy. Adv Hematol. 2017;2017:8690416. doi: 10.1155/2017/8690416. Epub 2017 Nov 8.
- Background: PubMed 28287639Passweg JR, Baldomero H, Bader P, Bonini C, Duarte RF, Dufour C, Gennery A, Kroger N, Kuball J, Lanza F, Montoto S, Nagler A, Snowden JA, Styczynski J, Mohty M. Use of haploidentical stem cell transplantation continues to increase: the 2015 European Society for Blood and Marrow Transplant activity survey report. Bone Marrow Transplant. 2017 Jun;52(6):811-817. doi: 10.1038/bmt.2017.34. Epub 2017 Mar 13.
- Background: PubMed 27313619Parmesar K, Raj K. Haploidentical Stem Cell Transplantation in Adult Haematological Malignancies. Adv Hematol. 2016;2016:3905907. doi: 10.1155/2016/3905907. Epub 2016 May 30.
- Background: PubMed 27034676Fabricius WA, Ramanathan M. Review on Haploidentical Hematopoietic Cell Transplantation in Patients with Hematologic Malignancies. Adv Hematol. 2016;2016:5726132. doi: 10.1155/2016/5726132. Epub 2016 Feb 29.
- Background: PubMed 24842530Bashey A, Solomon SR. T-cell replete haploidentical donor transplantation using post-transplant CY: an emerging standard-of-care option for patients who lack an HLA-identical sibling donor. Bone Marrow Transplant. 2014 Aug;49(8):999-1008. doi: 10.1038/bmt.2014.62. Epub 2014 May 19.
- Background: PubMed 24907627Koreth J, Kim HT, Nikiforow S, Milford EL, Armand P, Cutler C, Glotzbecker B, Ho VT, Antin JH, Soiffer RJ, Ritz J, Alyea EP 3rd. Donor chimerism early after reduced-intensity conditioning hematopoietic stem cell transplantation predicts relapse and survival. Biol Blood Marrow Transplant. 2014 Oct;20(10):1516-21. doi: 10.1016/j.bbmt.2014.05.025. Epub 2014 Jun 4.
- Background: PubMed 25016197Reshef R, Hexner EO, Loren AW, Frey NV, Stadtmauer EA, Luger SM, Mangan JK, Gill SI, Vassilev P, Lafferty KA, Smith J, Van Deerlin VM, Mick R, Porter DL. Early donor chimerism levels predict relapse and survival after allogeneic stem cell transplantation with reduced-intensity conditioning. Biol Blood Marrow Transplant. 2014 Nov;20(11):1758-66. doi: 10.1016/j.bbmt.2014.07.003. Epub 2014 Jul 10.
- BackgroundMathur, A and Malhotra, H. Haploidentical Stem Cell Transplantation: A Mini Review. J Stem Cell Res Ther 2017; 2(2): 00056.
- Background: PubMed 18162238Mattsson J, Ringden O, Storb R. Graft failure after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2008 Jan;14(1 Suppl 1):165-70. doi: 10.1016/j.bbmt.2007.10.025.
- BackgroundLegrand, F et al. Chimerism Analysis after Haploidentical Stem Cell Transplantation: Is It Necessary for All Patients? Blood 2016; 128: 3417.
- BackgroundHussain, A et al. Lineage-Specific Chimerism and Incidence of Graft Failure Following T-Cell Replete Haploidentical Transplantation Using Post-Transplant Cyclophosphamide in Eighty-Nine Consecutive Patients From a Single Center. Blood 2012; 120: 3030.
- Background: PubMed 19483157Moscardo F, Sanz J, Senent L, Cantero S, de la Rubia J, Montesinos P, Planelles D, Lorenzo I, Cervera J, Palau J, Sanz MA, Sanz GF. Impact of hematopoietic chimerism at day +14 on engraftment after unrelated donor umbilical cord blood transplantation for hematologic malignancies. Haematologica. 2009 Jun;94(6):827-32. doi: 10.3324/haematol.2008.000935.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Hill, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Stem-Cell Transplant, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients (time frame: 14 or 15 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689907, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 2 Nov 2026.