Who is sponsoring NCT04541277?

NCT04541277 is sponsored by Chinese PLA General Hospital.

What drugs are being tested in NCT04541277?

Interventions in NCT04541277: Tislelizumab.

What condition does NCT04541277 study?

NCT04541277 studies Acute Myeloid Leukemia, in Relapsed or Refractory, Acute Myeloid Leukemia, Elderly, Unfit, Acute Myeloid Leukemia With Positive Minimal Residual Disease.

Is NCT04541277 still recruiting?

NCT04541277 is currently status unknown. Last updated 9 September 2020.

Last reviewed 2020-09-09 · How we verify

NCT04541277

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combined Inhibition of PD-1 and DNA Hypomethylating Agent +/- Chemotherapy in High-risk AML or Elderly Patients With AML Who Are Unfit for Intensive Chemotherapy

Status unknown Phase 2 Last updated 9 September 2020

What this trial tests

Phase 2 trial testing Tislelizumab in Acute Myeloid Leukemia, in Relapsed or Refractory in 55 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
30 August 2021

30 August 2022

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	1 September 2020
Primary completion	30 August 2021
Estimated completion	30 August 2022
Sites	1 location across China

Drugs / interventions tested

Tislelizumab (TISLELIZUMAB) — full drug profile →

Conditions studied

Acute Myeloid Leukemia, in Relapsed or Refractory — all drugs for Acute Myeloid Leukemia, in Relapsed or Refractory →
Acute Myeloid Leukemia, Elderly, Unfit — all drugs for Acute Myeloid Leukemia, Elderly, Unfit →
Acute Myeloid Leukemia With Positive Minimal Residual Disease — all drugs for Acute Myeloid Leukemia With Positive Minimal Residual Disease →

Sponsor

Chinese PLA General Hospital

Who can join

18 and older, any sex, with Acute Myeloid Leukemia, in Relapsed or Refractory or Acute Myeloid Leukemia, Elderly, Unfit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well tislelizumab combined with DNA hypomethylation agent +/- CAG regimen (cytarabine, idarubicin / Aclarithromycin, rhG-CSF/ PEG-rhG-CSF) work in treating patients with high-risk acute myeloid leukemia (AML) or AML patients older than 60 years of age who are unfit for standard-dose chemotherapy. The expressions of PD-1 and PD-L1 are increased in AML cells. However, blocking the immune checkpoint alone has limited efficacy as a single agent in highly proliferative leukemia cells. During the recovery period after cytotoxic chemotherapy, the activation of PD-1/PD-L1 pathway may be increased and DNA hypomethylation agents can also up-regulate PD-1, PD-L1 and PD-L2 in AML patients. The up-regulation and activation of above immune checkpoint molecules are related to chemotherapy resistance. Therefore, adding chemotherapy and epigenetic regulation agents to Immune checkpoint blockade therapy may work better through overcoming drug resistance in AML treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Natural killer cell-based immunotherapy for acute myeloid leukemia.
Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
Targeting PD-1/PD-L1 pathway in myelodysplastic syndromes and acute myeloid leukemia.
Yang X, Ma L, Zhang X, Huang L, et al · · 2022 · cited 63× · PMID 35236415 · DOI 10.1186/s40164-022-00263-4
Prognostic and therapeutic implications of measurable residual disease in acute myeloid leukemia.
Aitken MJL, Ravandi F, Patel KP, Short NJ. · · 2021 · cited 40× · PMID 34479626 · DOI 10.1186/s13045-021-01148-5
Immunosuppressive Cell Subsets and Factors in Myeloid Leukemias.
Swatler J, Turos-Korgul L, Kozlowska E, Piwocka K. · · 2021 · cited 29× · PMID 33801964 · DOI 10.3390/cancers13061203
What Does the Economic Burden of Acute Myeloid Leukemia Treatment Look Like for the Next Decade? An Analysis of Key Findings, Challenges and Recommendations.
Forsythe A, Sandman K. · · 2021 · cited 16× · PMID 33981169 · DOI 10.2147/jbm.s279736
Single-center phase 2 study of PD-1 inhibitor combined with DNA hypomethylation agent + CAG regimen in patients with relapsed/refractory acute myeloid leukemia.
Gao XN, Su YF, Li MY, Jing Y, et al · · 2023 · cited 15× · PMID 37166484 · DOI 10.1007/s00262-023-03454-y
The AML immune paradox: decoding escape pathways and pioneering checkpoint, vaccine, and combination strategies.
Soleimani Samarkhazan H, Shafiei FS, Taghinejad Z, Maleknia M, et al · · 2025 · cited 14× · PMID 40634759 · DOI 10.1007/s10238-025-01795-9
Epigenetic regulators combined with tumour immunotherapy: current status and perspectives.
Zhang H, Pang Y, Yi L, Wang X, et al · · 2025 · cited 13× · PMID 40119465 · DOI 10.1186/s13148-025-01856-6

Verify or expand the search:

Other trials of Tislelizumab

Trials testing the same drug.

NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting

Other Chinese PLA General Hospital trials

Trials by the same sponsor.

NCT07294755 — The Impact of Intrapleural Block on Postoperative Pain Caused by Drainage Tubes After Thoracoscopic Surgery · NA · not yet recruiting
NCT07536607 — Predictive Role of Photon Counting Computed Tomography in Acute Coronary Syndrom Patients · not yet recruiting
NCT07489157 — Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy · NA · not yet recruiting
NCT07494981 — Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations · not yet recruiting
NCT07496008 — Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04541277 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chinese PLA General Hospital
Last refreshed: 9 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04541277.

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