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NCT04635384 · ClinicalTrials.gov registry record
Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test
A clinical trial of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by CareDx.
- Active
- Registry status
- 307
- Enrollment target
- 10
- Study locations
NCT04635384 is a study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by CareDx. The registered enrollment target is 307 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (167% higher). The trial reports 10 study locations across 9 states.
The verdict
NCT04635384, a study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by CareDx.
- ACTIVE NOT RECRUITING
- Registry status
- 307 participants
- Enrollment target
- 10
- Study locations
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, categorized as an unspecified phase. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (167% higher). The listed sponsor is CareDx, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 0 interventions.
NCT04635384 reports 10 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.
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.
Who is sponsoring clinical trial NCT04635384?
This trial is sponsored by CareDx, which has 8 total clinical trials registered on ClinicalTrials.gov.
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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