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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: Active study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by CareDx.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia

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

FieldValue
Enrollment Target 307 participants
Start Date 2021-06-30
Est. Completion 2026-08-31
CareDx

8 total trials

What the registry record for NCT04635384 still lists

NCT04635384 is an observational study that tracks outcomes without assigning an intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (167% higher).

The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 0 interventions.

NCT04635384 lists 10 locations in 9 states (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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04635384's enrollment target sits among peer trials

307 24th of 306 higher than 283 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04635384, the US trial registry maintained by the National Library of Medicine. NCT04635384 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.