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Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test (ACROBAT)

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ClinicalTrials.gov Identifier: NCT04635384
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
CareDx

Brief 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 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).

Condition or disease
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome

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.

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Chimerism and Relapse Post Bone Marrow/HCT Transplant Using AlloHeme Test (ACROBAT)
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Comparison of cumulative incidence of relapse post-transplant of patients with microchimerism vs. CC detected by AlloHeme

  2. 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 ]
    Comparison of DFS post-transplant in patients with iMC vs. complete chimerism (CC) vs. stable/decrease mixed chimerism (sMC/dMC) detected by AlloHeme.

  3. 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 ]
    Statistical correlation and agreement of peripheral blood donor chimerism quantitatively detected by AlloHeme and post-transplant MRD from bone marrow.

  4. 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 ]
    Comparison of performance AlloHeme versus STR-PCR method for post-transplant relapse prediction including Sensitivity Specificity, Positive predictive value, negative predictive value, AuROC


Biospecimen Retention:   Samples With DNA
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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635384


Contacts
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Contact: Nishant Dwivedi, MD/PhD +1 (508) 981-6087 ndwivedi@caredx.com

Locations
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United States, California
University of California Irvine Recruiting
Brisbane, California, United States, 94005
Contact: Elizabeth Chin    714-509-2414    chine6@hs.uci.edu   
Principal Investigator: Ciurea Stefan, MD         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Christian Makkar       cmakkar@coh.org   
Principal Investigator: Monzr A Malki, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Isabella Eisenhart    617-632-6715    isabella_eisenhart@dfci.harvard.edu   
Principal Investigator: Corey Cutler, MD         
United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christian A Gordillo    646-317-6238    cag2233@cumc.columbia.edu   
Principal Investigator: Ran Reshef, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Megan Zinser    216-442-0556    zinserm2@ccf.org   
Principal Investigator: Ronald Sobecks, MD         
Sponsors and Collaborators
CareDx
Investigators
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Study Director: Nishant Dwivedi, MD/PhD CareDx
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Responsible Party: CareDx
ClinicalTrials.gov Identifier: NCT04635384    
Other Study ID Numbers: SN-C-00014
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CareDx:
AML
ALL
MDS
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases