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Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test
NCT04635384 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Study Locations (10)
California
- University of California Irvine — Brisbane
- City of Hope — Duarte
Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa
Georgia
- Georgia Cancer Center at Augusta University — Augusta
Massachusetts
- Dana Farber Cancer Institute — Boston
Missouri
- Washington University in St. Louis — St Louis
New York
- Columbia University Irving Medical Center — New York
Ohio
- Cleveland Clinic Foundation — Cleveland
Oregon
- Oregon Health & Science University — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2026-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04635384
The ClinicalTrials.gov registry entry for NCT04635384 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CareDx, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04635384 reports 10 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04635384 about?
NCT04635384 is a clinical study titled "Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test". 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 baseli...
What is the current status of trial NCT04635384?
This trial is currently active not recruiting. The enrollment target is 307 participants. The study started on 2021-06-30. Estimated completion is 2026-08-31.
What conditions does trial NCT04635384 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04635384?
This trial is sponsored by CareDx, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04635384 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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