Clinical trial · Observational
MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse
Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse
NCT06000306CI-TRIAL-00068973completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Measurable Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Droplet PCR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ddPCR MRD positivity
- interventionNames
- Diagnostic Test: Digital Droplet PCR
- label
- ddPCR MRD negativity
- interventionNames
- Diagnostic Test: Digital Droplet PCR
Primary outcomes (1)
- measure
- Cumulative incidence of relapse (CIR)
- timeFrame
- At Year 2
- description
- The time from the date of transplantation to disease recurrence: Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring; 2. Successful stem cell engraftment 3. Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT; 4. Age 12-70 Exclusion Criteria: 1. Patients who relapsed or died before the first ddPCR monitoring; 2. Patients with only germline mutations.
References
Publications (1)
- DERIVEDChen W, Huang J, Zhao Y, Huang L, Yuan Z, Gu M, Xu X, Shi J, Luo Y, Yu J, Lai X, Liu L, Fu H, Bao C, Huang X, Zheng Z, Huang H, Hu X, Zhao Y. Measurable residual disease monitoring by ddPCR in the early posttransplant period complements the traditional MFC method to predict relapse after HSCT in AML/MDS: a multicenter retrospective study. J Transl Med. 2024 Apr 30;22(1):410. doi: 10.1186/s12967-024-05114-w. PMID 38689269