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

Study acronym: ACROBAT
StatusCompleted
PhaseNot specified
SponsorCareDx
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Nov 2026 to Sep 30, 2026
    • Start date pushed from Jun 30, 2021 to Jul 22, 2021
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised at 1 of 10 sites
  2. Primary completion pushed from May 31, 2026 to Oct 15, 2026
    • Study completion pushed from Aug 31, 2026 to Nov 2026
    v9
  3. Primary completion date: Oct 31, 2025 to May 31, 2026
    • Study completion date: Dec 31, 2025 to Aug 31, 2026
    v8
  4. Primary completion date: Dec 31, 2024 to Oct 31, 2025v7 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 260 to confirmed 307
    • Study sites: 5 to 10
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
  5. Study sites: 1 to 5v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 30, 2022 to Dec 31, 2024
    • Study sites: 0 to 1
    v5
  2. Start date: May 15, 2021 to Jun 30, 2021
    • Primary and study completion dates: May 14, 2022 to Jun 30, 2022
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Start date: Jan 15, 2021 to May 15, 2021
    • Primary and study completion dates: Jan 14, 2022 to May 14, 2022
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CareDx
6 trials monitored
See all monitored trials
Leukemia
2,957 trials monitored
See 176 trials at risk
Acute Myeloid Leukemia (AML)
1,275 trials monitored
See 74 trials at risk
Acute Lymphoblastic Leukemia (ALL)
934 trials monitored
See 55 trials at risk
and 1 more disease
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).
Trial Details
NCT Number NCT04635384
Lead Sponsor CareDx
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 307 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov