Table 1.
Clinical update of DNMT inhibitors
| Drug | Clinical studies |
|---|---|
| 5-Azacytidine | Azacytidine is undergoing the below mentioned studies: |
| Low-risk MDS (Phase III, NCT01566695, status—active, not recruiting) | |
| R/R T-cell lymphoma (Phase III, NCT03703375, status, recruiting) | |
| AML with complete remission (Phase III, NCT01757535, active, not recruiting) | |
| MDS patients with excess blasts, progressing (Azacitidine + rigosertib, Phase III, NCT01928537, status—active, not recruiting) | |
| AML, MDS, CML (Azacitidine + HAG regimen, Phase III, NCT03873311, not yet recruiting) | |
| AML (Azacitidine + venetoclax, NCT02993523, Phase III, status—recruiting) | |
| MDS (Azacitidine + APR-246, NCT03745716, Phase III, status—recruiting) | |
| AML, MDS, CML (Azacitidine + pevonedistat, Phase III, NCT03268954, status—recruiting) | |
| AML with IDH1 mutation (Azacitidine + AG-120, Phase III, NCT03173248, status—recruiting) | |
| AML (Azacitidine vs fludarabine + cytarabine, phase III, NCT02319135, status—active, not recruiting) | |
| AML (Azacitidine + intensive chemotherapy, phase III, NCT03416179, status—recruiting) | |
| Head and neck squamous cell carcinoma (Phase II, NCT02178072, status—recruiting) | |
| Pancreatic cancer (Phase II, NCT01845805, status—recruiting) | |
| Solid tumors and hematological disorders (Phase II, NCT02494258, status—recruiting) | |
| AML (Azacitidine + venetoclax, Phase II, NCT03466294, NCT03573024, status—recruiting) | |
| MDS, CMML and AML relapsing after allo-HSCT (Azacitidine + lenalidomide + DLI 50, Phase II, NCT02472691, status—active, not recruiting) | |
| MDS with excess blasts 2 (Azacitidine + vosaroxin, Phase II, NCT03338348, status—ecruiting) | |
| Advanced solid tumors (Azacitidine + durvalumab, Phase II, NCT02811497, status—recruiting) | |
| High-risk MDS, AML (Azacitidine + durvalumab, NCT02775903, Phase II, status—active, not recruiting) | |
| AML with NPM1 mutation (Azacitidine + pembrolizumab, Phase II, NCT03769532, status—not yet recruiting) | |
| Pancreatic cancer (Azacitidine + pembrolizumab, NCT03264404, Phase II, status—recruiting) | |
| Metastatic melanoma (Azacitidine + pembrolizumab, Phase II, NCT02816021, status—recruiting) | |
| MDS (Azacitidine + pembrolizumab, Phase II, NCT03094637, status—recruiting) | |
| Chemorefractory metastatic colorectal cancer (Azacitidine + pembrolizumab, Phase II, NCT02260440, status—active, not recruiting) | |
| Advanced or metastatic non-small-cell lung cancer (Azacitidine + pembrolizumab, Phase II, NCT02546986, status—active, not recruiting) | |
| Platinum-resistant ovarian cancer (Azacitidine + pembrolizuma, Phase II, NCT02900560, status—recruiting) | |
| Prostate cancer (Azacitidine + ATRA, Phase II, NCT03572387, status—recruiting) | |
| Recurrent or refractory disease with IDH2 mutation (Azacitidine + enasidenib, Phase II, NCT03683433, status—recruiting) | |
| High-risk MDS with IDH2 mutation (Azacitidine + enasidenib, Phase II, NCT03383575, status—recruiting) | |
| R/R AML (Azacitidine + pevonedistat, Phase II, NCT03745352, status—not yet recruiting) | |
| High-risk MDS, AML, CML (Azacitidine + pevonedistat, Phase II, NCT02610777, status—active, not recruiting) | |
| AML without remission after allogeneic stem cell transplantation (Azacitidine + pevonedistat, Phase II, NCT03709576, status—recruiting) | |
| MDS, AML and CMML (Azacitidine + PF-04449913, Phase II, NCT02367456, status—recruiting) | |
| PTCL (Azacitidine + CHOP, phase II, NCT03542266, status—recruiting) | |
| Advanced non-small-cell lung cancer (Azacitidine + paclitaxel, phase II, NCT02250326, status—active, not recruiting) | |
| MDS (Azacitidine + pevonedistat, Phase II, NCT03238248, status—recruiting) | |
| Elderly patients with AML (Azacitidine + gemtuzumab ozogamicin, Phase II, NCT00658814, status—active, not recruiting) | |
| Refractory/relapsed AML (Azacitidine + ipilimumab + nivolumab, Phase II, NCT02397720, status—recruiting) | |
| MDS (Azacitidine + nivolumab + ipilimumab, Phase II, NCT02530463, status—recruiting) | |
| High-risk MDS, AML (Azacitidine + sirolimus, Phase II, NCT01869114, status—recruiting) | |
| R/R diffuse large B-cell lymphoma (Azacitidine + rituximab, Phase II, NCT03719989, status—not yet recruiting) | |
| R/R AML (Azacitidine + avelumab, Phase I/II, NCT02953561, status—recruiting) | |
| R/R AML, MDS (Azacitidine + quizartinib, phase I/II, NCT01892371, status—recruiting) | |
| AML, high-risk MDS (Azacitidine + cytarabine + tosedostat, phase I/II, NCT01636609, status—active, not recruiting) | |
| MDS (Azacitidine + sonidegib, Phase I, NCT02129101, status—active, not recruiting) | |
| Decitabine (5-aza-2′deoxycytidine)-based trials | Decitabine is undergoing the below mentioned studies |
| R/R diffuse large B-cell lymphoma (Phase IV, NCT03579082, status—recruiting) | |
| R/R T lymphoblastic lymphoma (Decitabine, Phase IV, NCT03558412, status—recruiting) | |
| PTCL (Decitabine + CHOP, Phase III, NCT03553537, status—not yet recruiting) | |
| AML with TP53 mutation (Decitabine, phase II, NCT03063203, status—recruiting) | |
| AML (Decitabine + clofarabine, Phase II, NCT02085408, active, status—not recruiting) | |
| AML (Decitabine + bortezomib, phase II, NCT01420926, status—active, not recruiting) | |
| AML (Decitabine + cytarabine + daunorubicin hydrochloride, Phase II, NCT01627041, status—active, not recruiting) | |
| Relapsed FLT3-ITD-mutated AML, MDS (Decitabine + quizartinib, Phase I/II, NCT03661307, status—recruiting) | |
| AML (Decitabine + ruxolitinib, Phosphate, Phase I/II, NCT02257138, status—recruiting) | |
| Metastatic castration-resistant prostate cancer (Decitabine + enzalutamide, Phase I/II, NCT03709550, status—not yet recruiting) | |
| Guadecitabine (SGI-110)-based trials | Guadecitabine is currently being assessed in ASTRAL-2 (Phase III, R/R AML, NCT02920008) and ASTRAL-3 (phase III, MDSs (MDS) or chronic myelomonocytic leukemia, NCT02907359) |
| Guadecitabine is undergoing the below mentioned studies: MDS, CMML (Guadecitabine, NCT02907359, Phase III, status—recruiting) | |
| Philadelphia-negative MDS (Guadecitabine, Phase II, NCT03075826, status—recruiting) | |
| High-risk MDS (Guadecitabine, NCT02131597, Phase II, status—recruiting) | |
| MDS relapsing post AlloSCT (Guadecitabine + DLI, NCT02684162, Phase II, status—recruiting) | |
| Pembrolizumab, Phase II, NCT02901899, status—recruiting) | |
| Metastatic colorectal cancer (Guadecitabine + irinotecan, Phase II, NCT01896856, status—active, not recruiting) | |
| Refractory or resistant urothelial carcinoma (Guadecitabine + atezolizumab, Phase II, NCT03179943, status—recruiting) | |
| Refractory metastatic colorectal cancer (Guadecitabine + nivolumab, Phase I/II, NCT03576963, status—Not yet recruiting) | |
| Recurrent ovarian, primary peritoneal, or fallopian tube cancer (Guadecitabine + ) | |
| Advanced kidney cancer (Guadecitabine + durvalumab, Phase I/II, NCT03308396, status—recruiting) | |
| Advanced MDS CMML (Guadecitabine + atezolizumab, Phase I/II, NCT0293536 status—recruiting) | |
| Recurrent ovarian, fallopian tube, or primary peritoneal cancer (Guadecitabine + CDX-1401 Vaccine + atezolizumab, Phase I/II, NCT03206047, status—recruiting) | |
| AML, MDS (Guadecitabine + DLI, Phase I, NCT03454984, status—not yet recruiting) | |
| Hydralazine-based trials | Hydralazine is undergoing the below mentioned studies: |
| Ovarian cancer (Hydralazine + valproate, Phase III, NCT00533299, status—N/A) | |
| Cervical cancer (Hydralazine + valproate, Phase III, NCT00532818, status—N/A) | |
| Recurrent-persistent (cervical cancer, Hydralazine + valproate, Phase III, NCT02446652, status—N/A) |