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| Therapy Name | Cytarabine + Daunorubicin |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cytarabine | Cytosar-U | Ara-C | Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (PMID: 32524309). | |
| Daunorubicin | Cerubidine | Rubidomycin|daunomycin hydrochloride|rubomycin C|Acetyladriamycin | Chemotherapy - Anthracycline 13 | Cerubidine (daunorubicin) is an anthracycline, which inhibits DNA replication and repair. Cerubidine (daunorubicin) is FDA approved for AML and MLL (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02343939 | Phase Ib/II | Decitabine Cytarabine + Daunorubicin Entospletinib | Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML) | Terminated | USA | DEU | CAN | 0 |
| NCT07228273 | Phase II | Cytarabine + Daunorubicin Cytarabine + Fludarabine + Idarubicin + Venetoclax | Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia | Not yet recruiting | USA | 0 |
| NCT01546038 | Phase Ib/II | Glasdegib Cytarabine Decitabine Cytarabine + Daunorubicin | A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome | Completed | USA | POL | ITA | ESP | DEU | CAN | 0 |
| NCT04214249 | Phase II | Cytarabine + Daunorubicin Cytarabine Cytarabine + Idarubicin Pembrolizumab Cytarabine + Daunorubicin + Pembrolizumab Cytarabine + Pembrolizumab Cytarabine + Idarubicin + Pembrolizumab | BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
| NCT04801797 | Phase II | Azacitidine + Venetoclax Cytarabine + Idarubicin Cytarabine + Daunoxome Cytarabine + Daunorubicin | Venetoclax + Azacitidine vs. Induction Chemotherapy in AML | Recruiting | USA | 0 |
| NCT04628026 | Phase III | Cytarabine + Idarubicin + Venetoclax Cytarabine + Idarubicin Etoposide + Mitoxantrone + Venetoclax Etoposide + Mitoxantrone Cytarabine + Venetoclax Cytarabine + Daunorubicin + Venetoclax Cytarabine + Daunorubicin | Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2 | Recruiting | NOR | NLD | LTU | FIN | EST | DEU | BEL | AUT | 0 |
| NCT07007312 | Phase III | Cytarabine + Daunorubicin Azacitidine + Venetoclax Cytarabine + Daunorubicin + Ziftomenib Azacitidine + Venetoclax + Ziftomenib | Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML | Recruiting | USA | 0 |
| NCT04778397 | Phase III | Cytarabine + Idarubicin Azacitidine + Venetoclax Azacitidine + Magrolimab Cytarabine + Daunorubicin | Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated (ENHANCE-2) | Terminated | USA | SWE | ITA | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS | 2 |
| NCT02085408 | Phase III | Clofarabine Cytarabine + Daunorubicin | Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia | Completed | USA | ISR | 1 |
| NCT02416388 | Phase II | Cytarabine + Daunorubicin Cytarabine + Vosaroxin Cytarabine Methotrexate + Mycophenolic Acid Cyclosporine + Mycophenolic Acid Cytarabine + Venetoclax Cytarabine + Dexamethasone Cyclosporine Cytarabine + Idarubicin | Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR (BIG-1) | Recruiting | FRA | 0 |
| NCT04817241 | Phase Ib/II | Cytarabine + Daunorubicin Decitabine and Cedazuridine + Venetoclax | Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients | Active, not recruiting | USA | 0 |
| NCT01627041 | Phase II | Cytarabine + Daunorubicin + Decitabine Cytarabine + Daunorubicin | Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
| NCT05564390 | Phase II | Decitabine and Cedazuridine Fludarabine + Melphalan Decitabine and Cedazuridine + Enasidenib Decitabine and Cedazuridine + Olutasidenib Azacitidine + Gilteritinib + Venetoclax Decitabine and Cedazuridine + Venetoclax Cytarabine + Daunorubicin + Gemtuzumab ozogamicin CPX-351 Olutasidenib Decitabine and Cedazuridine + Enasidenib + Venetoclax Cytarabine + Venetoclax Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax Cytarabine + Daunorubicin Cytarabine Azacitidine + Venetoclax Decitabine and Cedazuridine + Olutasidenib + Venetoclax | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | Recruiting | USA | CAN | 1 |
| NCT05554393 | Phase II | Cytarabine + Daunorubicin Cytarabine + Daunorubicin + Venetoclax Azacitidine + Venetoclax | Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) | Recruiting | USA | CAN | 1 |
| NCT03701308 | Phase II | Cytarabine + Daunorubicin Cytarabine + Uproleselan Cytarabine + Daunorubicin + Uproleselan Cytarabine | Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy | Active, not recruiting | USA | 0 |
| NCT02403310 | Phase I | Cytarabine + Daunorubicin Selinexor | A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML | Completed | USA | 0 |
| NCT05554406 | Phase II | Cytarabine + Daunorubicin Azacitidine + Venetoclax CPX-351 Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax | Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) | Recruiting | USA | CAN | 1 |
| NCT03416179 | Phase III | Cytarabine Cytarabine + Daunorubicin + Glasdegib Azacitidine + Glasdegib Azacitidine Cytarabine + Daunorubicin | 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) | Completed | USA | SWE | ROU | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | AUS | 6 |
| NCT01806571 | Phase II | Cytarabine + Daunorubicin Nilotinib | Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | Completed | USA | 0 |
| NCT06578247 | Phase III | Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Cytarabine + Daunorubicin Cytarabine + Daunorubicin + Quizartinib | Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD) | Recruiting | USA | SWE | ROU | POL | NOR | ITA | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | 8 |