Evidence map›Paper›PMID 40313949›Full record

Trial reportFrontiers in immunology2025

Updates from a single-center phase 2 study of PD-1 inhibitor combined with hypomethylating agent plus CAG regimen in patients with relapsed/refractory acute myeloid leukemia.

Hui-Sheng Zhou, Yong-Feng Su, Jun Wang, Ya-Lei Hu, An Wang, Lei Xu, Yi-Zhi Wang, Xuan Zheng, Yu-Qing Li, Kai-Li Min and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04541277 (A Phase II, Single Arm Study of Tislelizumab Combined With DNA Demethylation Agent +/- CAG Regimen in the Treatment of Patients With High-risk AML or AML Patients Older Than 60 Years of Age Who Are Unfit for Intensive Chemotherapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04541277 phase2unknown statusnot on this map

A Phase II, Single Arm Study of Tislelizumab Combined With DNA Demethylation Agent +/- CAG Regimen in the Treatment of Patients With High-risk AML or AML Patients Older Than 60 Years of Age Who Are Unfit for Intensive Chemotherapy

TypeinterventionalSponsorChinese PLA General HospitalRan2020 to 2022Enrolled55ConditionsAcute Myeloid Leukemia, in Relapsed or Refractory, Acute Myeloid Leukemia, Elderly, Unfit, Acute Myeloid Leukemia With Positive Minimal Residual DiseaseArmsTislelizumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
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

13 authors.

Hui-Sheng Zhou *Senior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Yong-Feng Su *Senior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Jun Wang *Senior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Ya-Lei Hu *Senior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
An WangSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Lei XuSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Yi-Zhi WangSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Xuan ZhengSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Yu-Qing LiSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Kai-Li MinSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Chun-Ji GaoSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Dai-Hong LiuSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Xiao-Ning GaoSenior Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Anti-PD-1 monotherapy has shown limited clinical efficacy in patients with relapsed/refractory acute myeloid leukemia (r/r AML). Our study aimed to analyze the effectiveness and safety of combining tislelizumab with a hypomethylating agent (HMA) plus CAG regimen in treating patients with r/r AML, with an increased sample size and in comparison, with a historical control group for more reliable data support (ClinicalTrials.gov identifier NCT04541277). Methods: The study included a total of 37 patients with r/r AML who received the tislelizumab + HMA + CAG regimen. Results: The overall response rate was 69.4%, with a median overall survival of 12.1 months and event-free survival of 6.2 months. Multivariate analysis revealed that patients aged 40 or above exhibited a higher response rate, while those with lower leukemia burden (bone marrow blast percentage <40%) demonstrated improved overall survival and event-free survival. Additionally, bridging allogeneic hematopoietic stem cell transplantation was associated with extended event-free survival. Grade 2-3 immune-related adverse events were observed in 8.5% of patients, and no deaths were directly attributed to these events. After propensity score matching, the inclusion of tislelizumab appeared to positively influence the overall response rate and event-free survival compared to historical controls treated with HMA + CAG regimen. Discussion: Overall, the combination regimen improved response rates while maintaining low incidence and severity of immune-related adverse events for r/r AML patients. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT04541277.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsImmune Checkpoint InhibitorsLeukemia, Myeloid, AcuteProgrammed Cell Death 1 ReceptorAdultAgedAntibodies, Monoclonal, HumanizedCytarabineFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedCytarabineImmune Checkpoint InhibitorsProgrammed Cell Death 1 Receptortislelizumabacute myeloid leukemiaDNA hypomethylation agentPD-1 inhibitorrefractoryrelapse

Identifiers

PMID40313949
PMCPMC12043577

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.