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DRUG CLASS:

HDAC10 inhibitor

2d
New P2 trial • Metastases
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paclitaxel • docetaxel • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • irinotecan • Epidaza (chidamide)
2d
Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC) (clinicaltrials.gov)
P1, N=9, Terminated, Taipei Medical University Shuang Ho Hospital | Trial completion date: Dec 2024 --> Mar 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Mar 2024; The overall profile does not support development for metastatic colorectal cancer
Trial completion date • Trial termination • Trial primary completion date • Metastases
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • RAS mutation • RAS wild-type
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Epidaza (chidamide) • celecoxib oral
10d
Sustained yet non-curative response to lenalidomide in relapsed angioimmunoblastic T-cell lymphoma with acquired chidamide resistance: a case report with 10-year follow-up, genetic insights and literature review. (PubMed, Front Oncol)
Notably, genes commonly mutated in AITL, including RHOA, TET2, DNMT3A, and IDH2, were absent in this case. A review of the literature highlights the heterogeneous genomic landscape of AITL and the diversity of treatment options available, underscoring the importance of tailored approaches to overcome resistance and improve outcomes in this distinct lymphoma subtype.
Review • Journal
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IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • DNMT3A (DNA methyltransferase 1) • ARID1A (AT-rich interaction domain 1A) • TET2 (Tet Methylcytosine Dioxygenase 2) • KMT2D (Lysine Methyltransferase 2D) • RHOA (Ras homolog family member A)
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ARID1A mutation • TET2 mutation • KMT2D mutation • Chr del(5q)
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lenalidomide • Epidaza (chidamide)
17d
DEB: Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL (clinicaltrials.gov)
P3, N=423, Active, not recruiting, Chipscreen Biosciences, Ltd. | Trial completion date: Mar 2025 --> Jun 2025
Trial completion date • Combination therapy
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
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CD20 positive • MYC rearrangement
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide)
18d
Chidamide With Immunotherapy for Patients With Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
P2, N=45, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Oct 2025 | Trial primary completion date: Sep 2022 --> Aug 2024
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
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PD-L1 (Programmed death ligand 1)
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Tevimbra (tislelizumab-jsgr) • Epidaza (chidamide)
19d
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients (clinicaltrials.gov)
P3, N=430, Recruiting, Chipscreen Biosciences, Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
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Avastin (bevacizumab) • Tyvyt (sintilimab) • Fruzaqla (fruquintinib) • Epidaza (chidamide)
23d
HDAC Inhibitor Combination with Chemoimmunotherapy in the Neoadjuvant Treatment of PMMR Locally Advanced Colon Cancer (clinicaltrials.gov)
P2, N=100, Recruiting, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
New P2 trial • Metastases
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Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Epidaza (chidamide)
24d
Chidamide and venetoclax synergistically regulate the Wnt/β-catenin pathway by MYCN/DKK3 in B-ALL. (PubMed, Ann Hematol)
In our study, the in vitro and in vivo experiments confirmed that chidamide and venetoclax synergistically inhibited the expression of MYCN and increased the expression of DKK3 by inhibiting the activity of HDAC and BCL2, inhibiting the Wnt/β-catenin signaling pathway and B-ALL cell proliferation. These findings indicate that the HDACi chidamide and the BCL2 inhibitor venetoclax can be used in combination to treat B-ALL, providing a new method and strategy for treating B-ALL.
Journal • IO biomarker
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • DKK3 (Dickkopf WNT Signaling Pathway Inhibitor 3)
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MYCN expression
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Venclexta (venetoclax) • Epidaza (chidamide)
1m
New P2 trial • IO biomarker
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • decitabine • Epidaza (chidamide) • Inokai (orelabrutinib)
1m
Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia (clinicaltrials.gov)
P2, N=92, Recruiting, The First Affiliated Hospital of Soochow University | Trial primary completion date: Sep 2024 --> Sep 2025
Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2)
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Venclexta (venetoclax) • azacitidine • Epidaza (chidamide)
1m
RLC Followed by CR-CHOP in Elderly Patients with Newly-diagnosed DEL (clinicaltrials.gov)
P2, N=44, Recruiting, Zhejiang Cancer Hospital | Not yet recruiting --> Recruiting
Enrollment open
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Rituxan (rituximab) • lenalidomide • cyclophosphamide • epirubicin • Epidaza (chidamide) • vindesine
1m
Sincerely20: Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma (clinicaltrials.gov)
P2, N=51, Recruiting, Fudan University | Trial completion date: Sep 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
Trial completion date • Trial primary completion date • IO biomarker • Epigenetic controller
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PD-L1 expression
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Tyvyt (sintilimab) • Epidaza (chidamide)
1m
New P2 trial • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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capecitabine • vinorelbine tartrate • Epidaza (chidamide)
1m
New P2 trial • Combination therapy • Metastases
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR mutation • ALK fusion
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gemcitabine • Epidaza (chidamide) • Ariely (adebrelimab)
1m
Prospective, open-label, phase II clinical study of the combination of Chidamide and Anlotinib ± PD-1/PD-L1 inhibitors in patients with SWI/SNF complex-deficient mutations (ChiCTR2400090522)
P2, N=57, Recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
New P2 trial • IO biomarker
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ARID1A (AT-rich interaction domain 1A) • SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1) • SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
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Focus V (anlotinib) • Epidaza (chidamide)
1m
New P2 trial • Combination therapy • Metastases
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Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Epidaza (chidamide)
2ms
New P2 trial
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Rituxan (rituximab) • lenalidomide • cyclophosphamide • epirubicin • Epidaza (chidamide) • vindesine
2ms
Real-world efficacy of chidamide plus R-CHOP in newly diagnosed double-expressor diffuse large B-cell lymphoma. (PubMed, Ther Adv Hematol)
To evaluate the efficacy of a novel histone deacetylase inhibitor, chidamide, in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (CR-CHOP) in the treatment of DEL. The most common grades 3-4 hematologic and nonhematologic toxicity were leukopenia (46.7%) and infection (21%), respectively. This long-term follow-up study indicates that CR-CHOP in untreated DLBCL with the DEL phenotype demonstrates high short-term efficacy and safety as well as promising survival outcomes.
Journal • Real-world evidence • IO biomarker • Real-world effectiveness • Real-world
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
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BCL2 expression • MYC expression
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide)
2ms
New trial
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Epidaza (chidamide) • Folotyn (pralatrexate)
2ms
Chidamide Combined with (+) -JQ-1 to Kill MLL-Rearrangement Acute Myeloid Leukemia Cells by Disrupting the DNA Damage Response Pathway (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi)
Chidamide combined with (+)-JQ-1 can inhibit the proliferation of MLL-r AML cells, inhibit the initiation of protective self-repair of these leukemia cells by inhibiting the DNA damage response pathway, and ultimately increase the apoptosis of these cells, but non- MLL-r AML cells have no similar results.
Journal • IO biomarker
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BCL2 (B-cell CLL/lymphoma 2) • KMT2A (Lysine Methyltransferase 2A) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • CHEK1 (Checkpoint kinase 1) • BAX (BCL2-associated X protein) • CASP3 (Caspase 3) • BRD4 (Bromodomain Containing 4) • TP53BP1 (Tumor Protein P53 Binding Protein 1)
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MLL rearrangement • MLL rearrangement • BCL2 expression • BAX expression
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JQ-1 • Epidaza (chidamide)
2ms
Chidamide triggers pyroptosis in T-cell lymphoblastic lymphoma/leukemia via the FOXO1/GSDME axis. (PubMed, Chin Med J (Engl))
Our study suggested that chidamide exerts an antitumor effect on T-LBL/ALL and promotes a more inflammatory form of cell death via the FOXO1/GSDME axis, which provides a novel choice of targeted therapy for patients with T-LBL/ALL.
Journal
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CASP3 (Caspase 3) • FOXO1 (Forkhead box O1) • HDAC2 (Histone deacetylase 2) • HDAC1 (Histone Deacetylase 1) • GSDME (Gasdermin E) • HDAC3 (Histone Deacetylase 3)
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Epidaza (chidamide)
2ms
R-ICE+X: Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=76, Recruiting, Ruijin Hospital | Trial primary completion date: Jun 2024 --> Jun 2025
Trial primary completion date
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carboplatin • Brukinsa (zanubrutinib) • decitabine • Epidaza (chidamide) • pomalidomide • tofacitinib
2ms
New trial
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BCL2 (B-cell CLL/lymphoma 2)
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide)
2ms
Design, Synthesis, and Biological Evaluation of HDAC Inhibitors Containing Natural Product-Inspired N-Linked 2-Acetylpyrrole Cap. (PubMed, Molecules)
Among them, compound 20 exhibited potential inhibitory activity on HDAC1, and demonstrated notable potency against RPMI-8226 cells with an IC50 value of 2.89 ± 0.43 μM, which was better than chidamide (IC50 = 10.23 ± 1.02 μM)...The ADME parameters calculation showed that 20 possesses remarkable theoretical drug-likeness properties. Taken together, these results suggested that 20 is worthy of further exploration as a potential HDAC-targeted anticancer drug candidate.
Journal
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HDAC1 (Histone Deacetylase 1) • ANXA5 (Annexin A5)
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Epidaza (chidamide)
2ms
New P2 trial • Metastases
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Epidaza (chidamide) • Yidafan (ivonescimab)
2ms
HDAC10 inhibits non-small-cell lung cancer cell ferroptosis through the microRNA-223-5p-SLC7A11 axis. (PubMed, Toxicol Res (Camb))
The joint experimental results showed that overexpression of SLC7A11 or downregulation of miR-223-5p alleviated the promoting effect of silencing HDAC10 on ferroptosis in NSCLC cells. HDAC10 inhibits miR-223-5p expression through H3K9ac deacetylation of the miR-223-5p promoter, thereby promoting SLC7A11 expression and inhibiting ferroptosis in NSCLC cells.
Journal
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ACSL4 (Acyl-CoA Synthetase Long Chain Family Member 4) • SLC7A11 (Solute Carrier Family 7 Member 11) • MIR223 (MicroRNA 223) • HDAC10 (Histone Deacetylase 10)
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SLC7A11 expression
3ms
Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML (clinicaltrials.gov)
P2, N=30, Recruiting, The First Affiliated Hospital of Xiamen University | Trial completion date: Jan 2026 --> Jun 2027 | Trial primary completion date: Jan 2024 --> Jan 2026
Trial completion date • Trial primary completion date
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Venclexta (venetoclax) • azacitidine • Epidaza (chidamide)
3ms
Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov)
P2, N=55, Completed, HUYABIO International, LLC. | Phase classification: P2b --> P2 | N=40 --> 55
Phase classification • Enrollment change
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Epidaza (chidamide)
3ms
Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov)
P=N/A, N=184, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting
Enrollment open
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Venclexta (venetoclax) • azacitidine • Epidaza (chidamide)
3ms
New trial • Metastases
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AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Epidaza (chidamide) • Teysuno (gimeracil/oteracil/tegafur)
3ms
New P2 trial • Metastases
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gemcitabine • oxaliplatin • Epidaza (chidamide) • Kaitanni (cadonilimab)
3ms
Adebrelimab and Chidamide plus Gemcitabine as first-line treatment for advanced and metastatic pancreatic cancer patients (P-reCise/SCOG-P001): An exploratory, phase 2 trial. (ChiCTR2400079609)
P2, N=32, Recruiting, First affiliated hospital of Soochow university; First affiliated hospital of Soochow university | Not yet recruiting --> Recruiting | Phase classification: PN/A --> P2 | N=90 --> 32 | Initiation date: Jan 2024 --> Aug 2024
Enrollment open • Phase classification • Enrollment change • Trial initiation date • Metastases
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gemcitabine • Epidaza (chidamide) • Ariely (adebrelimab)
3ms
Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL) (clinicaltrials.gov)
P2, N=23, Completed, HUYABIO International, LLC. | Phase classification: P2b --> P2
Phase classification
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Epidaza (chidamide)
3ms
Cancer-Associated Fibroblasts Expressing Sulfatase 1 Facilitate VEGFA-Dependent Microenvironmental Remodeling to Support Colorectal Cancer. (PubMed, Cancer Res)
Importantly, tumor growth inhibition by HDAC inhibition was dependent on SULF1 expression in CAFs, and CRC patients with more SULF1+ CAFs were more responsive to treatment with the HDAC inhibitor chidamide. Collectively, these findings unveil the critical role of SULF1+ CAFs in CRC and provide a strategy to stratify CRC patients for HDAC inhibitor treatment.
Journal
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VEGFA (Vascular endothelial growth factor A)
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Epidaza (chidamide)
4ms
Chidamide maintenance therapy after allo-HSCT in SET-NUP214 fusion positive T-ALL patients: A report of two cases. (PubMed, Transpl Immunol)
Here we report chidamide maintenance therapy after allo-HSCT in patients with SET-NUP214 fusion positive T-ALL. Both patients improved effectively during follow-up, confirming the efficacy of chidamide in improving the condition of these patients and may provide valuable clinical information for the treatment of this rare and understudied disease.
Journal
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NUP214 (Nucleoporin 214)
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SET-NUP214 fusion
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Epidaza (chidamide)
4ms
Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL (clinicaltrials.gov)
P2, N=22, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial
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Epidaza (chidamide) • Columvi (glofitamab-gxbm)
4ms
Enrollment change • IO biomarker
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PD-1 (Programmed cell death 1)
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decitabine • Adcetris (brentuximab vedotin) • Epidaza (chidamide)
4ms
Targeted agents plus CHOP compared with CHOP as the first-line treatment for newly diagnosed patients with peripheral T-cell lymphoma (GUIDANCE-03): an open-label, multicentre phase 2 clinical trial. (PubMed, Lancet Reg Health West Pac)
We conducted an open-label, phase 2 nonrandomised, externally controlled study to evaluate the efficacy and safety of targeted agents plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) (CHOPX) for PTCL in the front-line setting...Specific targeted agents were added from Cycle 2, decitabine if TP53 mut, azacytidine if TET2/KMT2D mut, tucidinostat if CREBBP/EP300 mut, and lenalidomide if without mutations above...Biomarker-driven therapeutic strategy is feasible and may lead to promising efficacy specifically toward molecular features in PTCL. This study was supported by the National Key Research and Development Program (2022YFC2502600) and the General Program of the Shanghai Municipal Health Commission (202040400).
P2 data • Journal
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TP53 (Tumor protein P53) • TET2 (Tet Methylcytosine Dioxygenase 2) • KMT2D (Lysine Methyltransferase 2D) • CREBBP (CREB binding protein) • EP300 (E1A binding protein p300)
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lenalidomide • doxorubicin hydrochloride • azacitidine • cyclophosphamide • decitabine • vincristine • Epidaza (chidamide)
4ms
New P2 trial • IO biomarker
|
PD-1 (Programmed cell death 1)
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decitabine • Adcetris (brentuximab vedotin) • Epidaza (chidamide) • bendamustine
4ms
New P2 trial • Metastases
|
Epidaza (chidamide) • AiRuiKang (dalpiciclib)
4ms
New P2 trial
|
Epidaza (chidamide)
4ms
Chidamide induces cell cycle arrest via NR4A3/P21 axis upregulation to suppress relapsed and refractory acute myeloid leukemia. (PubMed, Biochem Biophys Res Commun)
We have discovered a novel epigenetic regulatory mechanism of chidamide in the treatment of relapsed and refractory acute myeloid leukemia (R/R AML).
Journal
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NR4A3 (Nuclear receptor subfamily 4 group A member 3) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
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Epidaza (chidamide)