Table 1.
This table shows phase III clinical trials for decitabine, azacytidine and bortezomib in hematological malignancies.
| Study Number | Status | Drug | Study Title | Phase | Masking | Indication/ Condition |
No./Type of Participants | Start/Completion Dates |
|---|---|---|---|---|---|---|---|---|
| NCT01809392 | Unknown | Decitabine | Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome | 2, 3 | Open label, non-randomized | Acute Myeloid Leukemia, Myelodysplastic Syndromes | 15 | Jan 2013–Dec 2015 |
| NCT03377725 | Unknown | Decitabine, Arsenic Trioxide | Decitabine and Arsenic Trioxide for Myelodysplastic Syndrome (MDS) | 3 | Single, randomized | Myelodysplastic Syndromes, P53 mutation |
300 | March 2018–Nov 2020 |
| NCT02744742 | Unknown | Decitabine, Busulfan (BU), Cyclophosphamide (CY), Granulocyte Colony-Stimulating Factor(G-CSF) | G-CSF+Decitabine+BUCY vs. BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT | 2, 3 | Open label, randomized | Myelodysplastic Syndrome, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning |
122 | March 2019–March 2020 |
| NCT02214407 | Active, not recruiting |
Decitabine, Hydroxyurea | Randomized Phase III Study of Decitabine +/− Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML (GFM-DAC-CMML) | 3 | Open label, randomized | Myelodysplastic Syndrome | 168 | Oct 2014–Oct 2021 |
| NCT02272478 | Recruiting | Arm A: Mylotarg plus DA Versus CPX-351, Arm B: Vosaroxin and Decitabine, Arm D: Small molecule or Not, Arm C: DA V FLAG-Ida V DAC, Arm E: CPX-351 (200 V 300), Arm F: DA V IDAC | Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations (AML18) | 2, 3 | Open label, randomized | Acute Myeloid Leukemia, Myelodysplastic Syndrome |
1600 | Feb 2021–Feb 2022 |
| NCT03306264 | Recruiting | ASTX727, Dacogen (decitabine) | Study of ASTX727 vs. IV Decitabine in MDS, CMML, and AML | 3 | Open label, randomized | Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia |
200 | Feb 2018–May 2022 |
| NCT02172872 | Active, not recruiting |
Standard combination chemotherapy, decitabine | “InDACtion” vs. “3 + 7” Induction in AML | 3 | Open label, randomized | Acute Myeloid Leukemia | 606 | Nov 2014–Dec 2022 |
| NCT04713956 | Recruiting | Granulocyte Colony-Stimulating Factor(G-CSF), Decitabine (DAC), Busulfan (BU), Cyclophosphamide (CY), Fludarabine (FLU) | G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT | 2, 3 | Open label, randomized | Myelodysplastic Syndrome, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning |
242 | Jan 2021–July 2024 |
| NCT02085408 | Active, not recruiting |
Clofarabine, daunorubicin hydrochloride, cytarabine, decitabine | Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia | 3 | Open label, randomized | Acute Myeloid Leukemia | 727 | Dec 2010–Oct 2024 |
| NCT04173533 | Recruiting | Oral Azacitidine, Matched placebo | Randomized Study of Oral Azacitidine vs. Placebo Maintenance in AML or MDS Patients After Allo-SCT (AMADEUS) | III | Double, Randomized | AML, Myelodysplasia | 324 | Jun 2019–Jun 2024 |
| NCT03092674 | Active, not recruiting |
Azacitidine, Cytarabine, Decitabine, Midostaurin | Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | II, III | Open Label, Randomized | AML, Myelodysplastic Syndrome | 1670 | Dec 2017–Aug 2023 |
| NCT03268954 | Recruiting | Azacitidine, Pevonedistat | Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) (PANTHER) | III | Open Label, Randomized | Myelodysplastic Syndrome (Leukemia, Myelonocytic, Chronic Leukemia, Myeloid, Acute) | 502 | Nov 2017–Feb 2025 |
| NCT00071799 | Completed | Azacitidine | A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care | III | Open Label, Randomized | Myelodysplastic Syndromes | 358 | Nov 2003–July 2007 |
| NCT04256317 | Recruiting | ASTX030 (Cedazuridine + Azacitidine) | A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML | II, III | Open Label, Randomized | MDS, CMML, AML | 245 | May 2020–Apr 2023 |
| NCT03978364 | Recruiting | Azacitidine combined HHT, Azacitidine regimen | A Study of Azacitidine for Patients With Int/High -Risk MDS and AML-MRC | III | Open Label, Randomized | Myelodysplastic Syndrome, AML | 100 | Jun 2019–Dec 2022 |
| NCT00887068 | Completed | Azacitidine | Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129) | III | Open Label, Randomized | AML, MDS | 187 | Apr 2009–Aug 2018 |
| NCT03173248 | Recruiting | AG-120 (ivosidenib) with Azacitidine, Placebo with Azacitidine | Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE) | III | Triple. Randomized | AML (Newly Diagnosed, Untreated AML, AML arising from MDS, Leukemia, Myeloid, Acute | 200 | Jun 2017–Jun 2022 |
| NCT04842604 | New, not yet recruiting |
Glasdegib, Azacitidine | Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML | III | Open Label, Non-Randomized | AML, MDS, CMML | 37 | Apr 2021–Dec 2022 |
| NCT04401748 | Recruiting | Venetoclax, Azacitidine, Placebo | Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome (Verona) | III | Quadruple, Randomized | MDS | 500 | Sep 2020–Feb 2025 |
| NCT01566695 | Active, not recruiting |
Venetoclax, Azacitidine, Placebo | The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS) | III | Quadruple, Randomized | Myelodysplastic Syndrome | 216 | Apr 2013–Dec 2021 |
| NCT04313881 | Recruiting | Magrolimab, Azacitidine, Placebo | Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) (ENHANCE) | III | Double, Randomized | Myelodysplastic Syndrome | 520 | Sep 2020–Aug 2025 |
| NCT03416179 | Active, not recruiting |
Glasdegib, Daunorubicin + Cytarabine, Azacitidine, Placebo | A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019) | III | Quadruple, Randomized | Untreated AML, Leukemia, Myeloid, Acute | 731 | Apr 2018–Dec 2022 |
| NCT01109004 | Completed | Lenalidomide, bortezomib, dexamethasone | Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702) | 3 | Open label, randomized | Multiple Myeloma | 758 | May 2010–March 2018 |
| NCT02811978 | Completed | Bortezomib (Velcade), Dexamethasone | Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma | 3 | Open label, randomized | Multiple Myeloma | 81 | Sept 2016–Nov 2018 |
| NCT01146834 | Completed | Bortezomib (Velcade), cyclophosphamide, G-CSF, Plerixafor | Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma | 3 | Open label, randomized | Multiple Myeloma | 47 | March 2011–Feb 2019 |
| NCT02112916 | Active, not recruiting |
Bortezomib | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma | 3 | Open label, randomized | T-Cell Acute Lymphoblastic Leukemia, Stage II-IV T-Cell Lymphoblastic Lymphoma | 844 | Sept 2014–March 2020 |
| NCT02195479 | Active, not recruiting |
Velcade, Melphalan, Prednisone, Daratumumab IV and SC, Dexamethasone | A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma | 3 | Open label, randomized | Multiple myeloma | 706 | Dec 2014–Oct 2021 |
| NCT02136134 | Active, not recruiting |
Bortezomib, Daratumumab | Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma | 3 | Open label, randomized | Multiple Myeloma | 499 | Jan 2014–Sept 2021 |
| NCT01208662 | Active, not recruiting |
Lenalidomide, Bortezomib, Dexamethasone |
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs. High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106) | 3 | Open label, randomized | Multiple Myeloma | 660 | Sept 2010–Sept 2023 |
| NCT03110562 | Active, not recruiting |
Bortezomib, Selinexor, Dexamethasone | Bortezomib, Selinexor, and Dexamethasone in Patients with Multiple Myeloma (BOSTON) | 3 | Open label, randomized | Multiple Myeloma | 402 | May 2017–Sept 2023 |
| NCT01371981 | Active, not recruiting |
Bortezomib, Sorafenib Tosylate | Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | 3 | Open label, randomized | Acute Myeloid Leukemia | 1645 | June 2011–Sept 2027 |