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Clinical Trial NCT07500441 for Acute Myeloid Leukemia (AML) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML 100 Observational Overall Survival
Clinical Trial NCT07500441 is an observational study for Acute Myeloid Leukemia (AML) that is recruiting. It started on March 20, 2026 with plans to enroll 100 participants. Led by Peking University People's Hospital, it is expected to complete by December 31, 2029. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
This prospective observational study aims to evaluate the clinical significance of measurable residual disease (MRD) monitoring using digital PCR (dPCR) in patients with acute myeloid leukemia (AML) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study will specifically enroll patients harboring clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations.
Patient-specifi...
Show MoreDetailed Description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potentially curative treatment for patients with intermediate- and high-risk acute myeloid leukemia (AML). Post-transplant monitoring of measurable residual disease (MRD) is critical for early detection of relapse and timely clinical intervention.
This study focuses on AML patients harboring clonal hematopoiesis (CH) and/or myelodysplasia-relat...
Show MoreOfficial Title
Digital PCR-Based Detection of CHIP and MR Mutations for Minimal Residual Disease Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia (AML)Other Study IDs
- 2026PHB191-001
NCT ID Number
Start Date (Actual)
2026-03-20
Last Update Posted
2026-03-30
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Keywords
Measurable Residual Disease (MRD)
Digital PCR (DPCR)
Allogeneic Hematopoietic Stem Cell Transplantation
Clonal Hematopoiesis
Digital PCR (DPCR)
Allogeneic Hematopoietic Stem Cell Transplantation
Clonal Hematopoiesis
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
AML post-HSCT Cohort Patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) who harbor clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations, and are negative for recurrent fusion genes and NPM1 mutations. | Individualized Digital PCR (dPCR) monitoring Bone marrow samples are collected at 0, 1, 2, 3, 4.5, 6, 9, and 12 months post-HSCT. DNA is extracted and specific CH/MR mutation burden is quantified using individualized dPCR primer/probe systems. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cumulative Incidence of Relapse (CIR) | CIR is defined as the time from transplantation to hematologic or extramedullary relapse | Up to 2 years post-transplantation |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival (OS) | The time from HSCT to the Death from any cause | Up to 2 years post-transplantation |
Relapse-free survival (RFS) | The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence | Up to 2 years post-transplantation |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
- Diagnosis of acute myeloid leukemia (AML).
- Undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the investigating center.
- Negative for recurrent fusion genes routinely monitored in the clinical laboratory, including but not limited to AML1::ETO, CBFB::MYH11, KMT2A (MLL) rearrangements, NUP98::NSD1, NUP98::HOXA9, FUS::ERG, DEK::NUP214, SET::NUP214, PICALM::AF10, and BCR::ABL1.
- Availability of next-generation sequencing (NGS) results at initial diagnosis with accessible original reports.
- Negative for NPM1 mutations at initial diagnosis.
- Presence of clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations at initial diagnosis, including but not limited to DNMT3A, TET2, ASXL1, SRSF2, SF3B1, U2AF1, JAK2, IDH2, BCOR, EZH2, RUNX1, STAG2, and ZRSR2.
- Patients with mutation profiles unsuitable for the design of patient-specific digital PCR (dPCR) assays achieving a sensitivity of ≤0.1%.
- Absence of evaluable molecular targets for longitudinal MRD monitoring.
Peking University People's HospitalStudy Responsible Party
Meng Lv, Principal Investigator, Chief Physician & Associate Professor, Peking University People's Hospital
Study Central Contact
Contact: Meng Lv, M.D,Ph.D, +861088324637, [email protected]
Contact: Ya-zhen Qin, Ph.D, +861088324702, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Peking University People's Hospital, Beijing, Beijing Municipality, China
Recruiting