Acute Myeloid LeukemiaACROBATNCT04635384
Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by CareDx at 10 sites in United States.
Trial summary
AlloHeme is a chimerism test service that utilizes NGS technology to analyze SNP loci to quantify donor and recipient cells by measuring genomic DNA. Before transplant, patient and donor peripheral blood sample will be collected to identify informative marker for routine chimerism testing and baseline establishment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- How many people
- 307 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 Jul 2021to 30 Sep 2026
- 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: Participants aged > 18 years old with a diagnosis of AML, ALL, and MDS who will undergo an Allo-HCT will be invited to participate and enrolled into the study at the time initial transplant evaluation or at any time before admission for transplantation.
Who may be able to join
- Male or female, aged 18 years or above.
- The patient must have one of the following diseases: AML, ALL or MDS
- Eligible for allogeneic hematopoietic stem cell transplant
- Subjects must receive an Allo-HCT from an HLA matched related or unrelated donor or haploidentical donor
- Myeloablative or reduced intensity/non-myeloablative conditioning
- Any GVHD prophylaxis regimen including post-transplantation cyclophosphamide-based or conventional regimen
- The subject must be enrolled prior to Allo-HCT
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Has history of prior Allo-HCT
- T cell depleted transplant (Including in vivo and ex vivo T cell depletion)
- Inability to comply with medical recommendations or follow-up
- Donor is identical twin
- Pregnancy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of California Irvine
Brisbane, California, 94005
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
Columbia University Irving Medical Center
New York, New York, 10032
Oregon Health & Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84112
Washington University in St. Louis
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Assessment of Chimerism and Relapse Post Bone Marrow/HCT Transplant Using AlloHeme Test (ACROBAT)
AlloHeme is a chimerism test service that utilizes NGS technology to analyze SNP loci to quantify donor and recipient cells by measuring genomic DNA. Before transplant, patient and donor peripheral blood sample will be collected to identify informative marker for routine chimerism testing and baseline establishment for AlloHeme. Post-transplant blood or bone marrow samples are obtained and compared to the baseline sample profiles to calculate % chimerism of recipient cells in the blood and/or bone marrow samples. Cell selection from blood and bone marrow samples is applied to evaluate chimerism in specific cell subtypes that are relevant to AML and MDS diseases (CD3+ T lymphocytes, CD33+ Myeloid cells and CD15+ Granulocyte cell subtypes from blood and CD34+ hematopoietic stem cells from bone marrow).
Read the detailed description
The test will be started from month 1 post HCT and will be performed bi-weekly up to month 3, monthly from month 4-6 and quarterly from month 9 to year 2 for total 15 visits. During each visit, about 18 ml (3.6 teaspoons) of whole blood will be collected into 3 pink BD Hemogard tubes with K2 EDTA additive. In addition to blood collection, the subject will be asked to provide 3ml or 0.6 teaspoon of bone marrow specimens during the routine visits on Day 100(month 3), Day 180 and Day 360 for use in this research study. When bone marrow study is performed, marrow specimen will be collected for AlloHeme test at central lab. Standard chimerism assessment, bone marrow study and MRD test will be performed at each participated institution lab as clinically indicated and based on treating physician's discretion. Method of standard of care chimerism and MRD assessment will be based on each institutional standard protocol. Data related to AlloHeme test, clinical outcomes, PHI and all standard of care of patient management information will be collected from medical records. During the Baseline and pre transplant the following clinical data will be collected: sex, age, donor and recipient demographic, chemotherapy, remission status pre-transplant, donor type, HLA, stem cell source, conditioning regimen type and intensity, cytogenetics test, minimal residual disease, chimerism, T cell depletion and GVHD protocol. Following transplantation, clinical events including death, relapse, second allo-HSCT, DLI as well as the events that impact the chimerism like tapering IST, GVHD and infection will be collected.
- Keywords
- AML, ALL, MDS
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the association between increased mixed chimerism (iMC) detected by AlloHeme and post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome.
Comparison of cumulative incidence of relapse post-transplant of patients with increased mixed chimerism (iMC) vs. complete chimerism (CC) vs. stable/decrease mixed chimerism (sMC/dMC) detected by AlloHeme.
Measured: Jan-2022
Secondary outcomes (4)
To determine the association of microchimerism detected by AlloHeme on post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome
Comparison of cumulative incidence of relapse post-transplant of patients with microchimerism vs. CC detected by AlloHeme
Measured: Jan-2022
To determine the association between an iMC detected by AlloHeme and disease-free survival (DFS) post-transplant in patients with acute leukemia and myelodysplastic syndrome
Comparison of DFS post-transplant in patients with iMC vs. complete chimerism (CC) vs. stable/decrease mixed chimerism (sMC/dMC) detected by AlloHeme.
Measured: Jan-2022
To determine the correlation between peripheral blood chimerism detected by AlloHeme and post-transplant measurable residual disease (MRD) status in patients with acute leukemia and myelodysplastic syndrome
Statistical correlation and agreement of peripheral blood donor chimerism quantitatively detected by AlloHeme and post-transplant MRD from bone marrow.
Measured: Jan-2022
To compare the performance of post-transplant chimerism measured by AlloHeme versus STR-PCR method for post-transplant relapse prediction in patients with acute leukemia and myelodysplastic syndrome.
Comparison of performance AlloHeme versus STR-PCR method for post-transplant relapse prediction including Sensitivity Specificity, Positive predictive value, negative predictive value, AuROC
Measured: Jan-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start22 Jul 2021
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nishant Dwivedi, MD/PhD, Study director, CareDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635384
- Sponsor's protocol ID
- SN-C-00014
- Acronym
- ACROBAT
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Chimerism and Relapse Post Bone Marrow/HCT Transplant Using AlloHeme Test (ACROBAT)
- ClinicalTrials.gov ID
- NCT04635384
- Acronym / sponsor ID
- ACROBAT / SN-C-00014
- Keywords
- AML, ALL, MDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 19 Nov 2020 (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.
AlloHeme is a chimerism test service that utilizes NGS technology to analyze SNP loci to quantify donor and recipient cells by measuring genomic DNA. Before transplant, patient and donor peripheral blood sample will be collected to identify informative marker for routine chimerism testing and baseline establishment for AlloHeme. Post-transplant blood or bone marrow samples are obtained and compared to the baseline sample profiles to calculate % chimerism of recipient cells in the blood and/or bone marrow samples. Cell selection from blood and bone marrow samples is applied to evaluate chimerism in specific cell subtypes that are relevant to AML and MDS diseases (CD3+ T lymphocytes, CD33+ Myeloid cells and CD15+ Granulocyte cell subtypes from blood and CD34+ hematopoietic stem cells from bone marrow).
Detailed description
The test will be started from month 1 post HCT and will be performed bi-weekly up to month 3, monthly from month 4-6 and quarterly from month 9 to year 2 for total 15 visits. During each visit, about 18 ml (3.6 teaspoons) of whole blood will be collected into 3 pink BD Hemogard tubes with K2 EDTA additive. In addition to blood collection, the subject will be asked to provide 3ml or 0.6 teaspoon of bone marrow specimens during the routine visits on Day 100(month 3), Day 180 and Day 360 for use in this research study. When bone marrow study is performed, marrow specimen will be collected for AlloHeme test at central lab. Standard chimerism assessment, bone marrow study and MRD test will be performed at each participated institution lab as clinically indicated and based on treating physician's discretion. Method of standard of care chimerism and MRD assessment will be based on each institutional standard protocol. Data related to AlloHeme test, clinical outcomes, PHI and all standard of care of patient management information will be collected from medical records. During the Baseline and pre transplant the following clinical data will be collected: sex, age, donor and recipient demographic, chemotherapy, remission status pre-transplant, donor type, HLA, stem cell source, conditioning regimen type and intensity, cytogenetics test, minimal residual disease, chimerism, T cell depletion and GVHD protocol. Following transplantation, clinical events including death, relapse, second allo-HSCT, DLI as well as the events that impact the chimerism like tapering IST, GVHD and infection will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged > 18 years old with a diagnosis of AML, ALL, and MDS who will undergo an Allo-HCT will be invited to participate and enrolled into the study at the time initial transplant evaluation or at any time before admission for transplantation.
Key inclusion criteria (7 listed)
- Male or female, aged 18 years or above.
- The patient must have one of the following diseases: AML, ALL or MDS
- Eligible for allogeneic hematopoietic stem cell transplant
- Subjects must receive an Allo-HCT from an HLA matched related or unrelated donor or haploidentical donor
- Myeloablative or reduced intensity/non-myeloablative conditioning
Key exclusion criteria (6 listed)
- Has history of prior Allo-HCT
- T cell depleted transplant (Including in vivo and ex vivo T cell depletion)
- Inability to comply with medical recommendations or follow-up
- Donor is identical twin
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the association between increased mixed chimerism (iMC) detected by AlloHeme and post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome.
Time frame: Jan-2022
Comparison of cumulative incidence of relapse post-transplant of patients with increased mixed chimerism (iMC) vs. complete chimerism (CC) vs. stable/decrease mixed chimerism (sMC/dMC) detected by AlloHeme.
4 secondary outcomes
To determine the association of microchimerism detected by AlloHeme on post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome
Time frame: Jan-2022
To determine the association between an iMC detected by AlloHeme and disease-free survival (DFS) post-transplant in patients with acute leukemia and myelodysplastic syndrome
Time frame: Jan-2022
To determine the correlation between peripheral blood chimerism detected by AlloHeme and post-transplant measurable residual disease (MRD) status in patients with acute leukemia and myelodysplastic syndrome
Time frame: Jan-2022
To compare the performance of post-transplant chimerism measured by AlloHeme versus STR-PCR method for post-transplant relapse prediction in patients with acute leukemia and myelodysplastic syndrome.
Time frame: Jan-2022
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 16 Oct 2026.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Nishant Dwivedi, MD/PhD study director
CareDx
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by CareDx at 10 sites 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 7 inclusion and 6 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
To determine the association between increased mixed chimerism (iMC) detected by AlloHeme and post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome. (time frame: Jan-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.