Evidence map›Paper›PMID 42126687›Full record

Observational studyClinical and experimental medicine2026

Ultra-Low BCR::ABL1 positivity by digital PCR does not improve post-transplant risk stratification beyond real-time PCR in Ph+ acute lymphoblastic leukemia post-transplant.

Ya Luo, Wen-Min Chen, Xiao-Su Zhao, Ying-Jun Chang, Ting Zhao, Ying Wu, Yi-Fei Cheng, Xiao-Dong Mo, Yu-Qian Sun, Yu Wang and 5 more

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Clinical and experimental medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06211166 (Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06211166 recruitingnot on this map

Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD

TypeobservationalSponsorPeking University People's HospitalRan2024 to 2027Enrolled300ConditionsAcute Leukemia, MDS, MDS/MPN, CMLArmsDigital PCR, Quantitative PCR, MFC
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Ya Luo *Beijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Wen-Min Chen *Beijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Xiao-Su ZhaoBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Ying-Jun ChangBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Ting ZhaoBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Ying WuBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Yi-Fei ChengBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Xiao-Dong MoBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Yu-Qian SunBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Yu WangBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Lan-Ping XuBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Xiao-Hui ZhangBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Xiao-Jun HuangBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Ya-Zhen QinBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China. qin2000@aliyun.com.
Meng LvBeijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China. drlvmeng@bjmu.edu.cn.

Funding

Beijing Research Ward Excellence Program BRWEP2024W134080103National Key Research and Development Plan of China 2021YFA1100902National Natural Science Foundation of China 82370160Peking University People's Hospital RZ2024-01
6 · The paper itself

Abstract

backgroundPost-transplant relapse remains a major clinical challenge in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL). Real-time quantitative PCR (RQ-PCR) for BCR::ABL1 is the current standard for measurable residual disease (MRD) monitoring, whereas digital PCR (dPCR) offers substantially higher analytical sensitivity. Whether this increased sensitivity translates into additional prognostic value after allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains unclear.

methodsIn this prospective study (NCT06211166), 270 patients with Ph + ALL were longitudinally monitored after allo-HSCT. MRD was assessed in parallel using dPCR, RQ-PCR, and MFC. Based on the first post-transplant MRD detection pattern, patients were categorized into four groups: double-negative (n = 80), dPCR-single-positive (n = 158), RQ-PCR-single-positive (n = 3), and double-positive (n = 29).

resultsThe dPCR-single-positive pattern was the most prevalent MRD status, accounting for 58.5% of patients. dPCR positivity independently predicted subsequent MFC-MRD conversion (HR 9.56, P = 0.029), with a median lead time of 77 days. In addition, dPCR detected BCR::ABL1 positivity earlier than RQ-PCR, preceding subsequent hematologic relapse by a median of 64.5 and 91.5 days, respectively. However, the cumulative incidence of hematologic relapse (CIR), the primary endpoint of this study, did not differ significantly among the four MRD-defined groups (P = 0.60). Consistently, isolated dPCR positivity was not associated with inferior 2-year leukemia-free survival (LFS; P = 0.30) or overall survival (OS; P = 0.60).

conclusionsAlthough dPCR detects molecular disease earlier and anticipates MFC-MRD by 2 months after allo-HSCT in Ph + ALL, isolated ultra-low-level BCR::ABL1 positivity does not impact relapse risk, LFS, or OS. Routine MRD monitoring with RQ-PCR plus MFC remains sufficient for prognostic stratification, while dPCR primarily provides an ultra-early signal to guide timely intervention rather than improving survival prediction.

Indexed as

Fusion Proteins, bcr-ablHematopoietic Stem Cell TransplantationNeoplasm, ResidualPolymerase Chain ReactionPrecursor Cell Lymphoblastic Leukemia-LymphomaAdolescentAdultChildChild, PreschoolFemaleHumansMaleMiddle AgedPrognosisProspective StudiesProto-Oncogene Proteins c-ablABL1 protein, humanBCR-ABL1 fusion protein, humanFusion Proteins, bcr-ablProto-Oncogene Proteins c-ablBCR::ABL1Digital PCRMeasurable residual diseasePh + ALL

Identifiers

PMID42126687
PMCPMC13341713

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Registered trials

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