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
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Condition or disease |
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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome |
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 |
- 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.
- 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
- 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.
- 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.
- 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
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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 |
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
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
Contact: Nishant Dwivedi, MD/PhD | +1 (508) 981-6087 | ndwivedi@caredx.com |
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 |
Study Director: | Nishant Dwivedi, MD/PhD | CareDx |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
AML ALL MDS |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Hematologic Diseases |
Bone Marrow Diseases Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |