Therapy Detail

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Therapy Name Cytarabine
Synonyms
Therapy Description

Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (NCI Drug Dictionary).

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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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KMT2A rearrange acute lymphoblastic leukemia sensitive Cytarabine Preclinical - Cell line xenograft Actionable In a preclinical study, Cytosar-U (cytarabine) decreased leukemic cells by 66% in acute lymphocytic leukemia cell line xenograft models harboring a KMT2A rearrangement (PMID: 27443263). 27443263

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01870596 Phase II Cytarabine MK-8776 Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia Completed USA 0
NCT02535806 Phase II Vincristine Sulfate Bortezomib Pegaspargase Methotrexate Cytarabine Mitoxantrone Prednisone Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults Terminated USA 0
NCT02043587 Phase II Rituximab Pegaspargase Methotrexate Cytarabine Leucovorin Cyclophosphamide Dasatinib Daunorubicin Vincristine Sulfate Etoposide Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma Active, not recruiting USA 0
NCT02419755 Phase II Cytarabine Mercaptopurine Methotrexate Pegaspargase Vorinostat Doxorubicin Bortezomib Dexamethasone Mitoxantrone Prednisone Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies Terminated USA 0
NCT01515527 Phase II Cytarabine Cladribine Decitabine Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) Recruiting USA 0
NCT04029688 Phase Ib/II Idasanutlin + Venetoclax Cyclophosphamide + Idasanutlin + Topotecan Cytarabine + Fludarabine + Idasanutlin Cytarabine + Hydrocortisone + Methotrexate Cytarabine Methotrexate Idasanutlin Cyclophosphamide + Idasanutlin A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors Recruiting USA | CAN 4
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 Recruiting USA 0
NCT01187810 Phase I Fenretinide Cytarabine Methotrexate Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL Completed USA 0
NCT00549848 Phase III Daunorubicin + Pegaspargase + Vincristine Sulfate Cytarabine Mercaptopurine Thioguanine Clofarabine + Cyclophosphamide + Etoposide Methotrexate Dasatinib Doxorubicin Dexamethasone Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Active, not recruiting USA 0
NCT03117751 Phase II Cyclophosphamide Vincristine Sulfate Idarubicin Blinatumomab Doxorubicin Clofarabine Vorinostat Ruxolitinib Prednisone Bortezomib Etoposide Dasatinib Daunorubicin Dexamethasone Rituximab Methotrexate Cytarabine Mercaptopurine Pegaspargase Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma Recruiting USA 0
NCT03319901 Phase I Cytarabine Mercaptopurine Methotrexate Cyclophosphamide Venetoclax Doxorubicin Etoposide Vincristine Sulfate Venetoclax and Chemotherapy In ALL Recruiting USA 0
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) Active, not recruiting USA | CAN 20
NCT02756572 Phase I Sirolimus Mycophenolate mofetil Cyclosporine Cytarabine Melphalan Cladribine Filgrastim mitoxantrone hydrochloride Fludarabine Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myelodysplastic Syndrome or Acute Myeloid Leukemia Completed USA 0
NCT03571321 Phase I Pegaspargase Methotrexate Cytarabine Mercaptopurine Thioguanine Ruxolitinib Cyclophosphamide Dexamethasone Vincristine Sulfate Rituximab Doxorubicin Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia Recruiting USA 0
NCT04107727 Phase II Cytarabine Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Quizartinib Cytarabine + Quizartinib Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) Recruiting 1
NCT03069352 Phase III Cytarabine + Venetoclax Cytarabine A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy Active, not recruiting USA | CAN 22
NCT02203526 Phase I Dexamethasone + Etoposide + Ibrutinib + Pegylated liposomal-doxorubicin + Temozolomide Cytarabine Rituximab Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Dose-Adjusted-Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (DA-TEDDI-R) in Primary CNS Lymphoma 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 | CAN 4
NCT02577406 Phase III Azacitidine Cytarabine Enasidenib An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (IDHENTIFY) Active, not recruiting USA | CAN 16
NCT02920008 Phase III Decitabine Azacitidine Cytarabine Guadecitabine Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Completed USA | CAN 13
NCT03226418 Phase II Cytarabine Decitabine + Venetoclax Azacitidine + Venetoclax CPX-351 Cytarabine + Idarubicin Azacitidine + Glasdegib Decitabine + Glasdegib Cytarabine, Idarubicin, Liposome-encapsulated Daunorubicin-Cytarabine or Decitabine in Treating Older Patients With Acute Myeloid Leukemia Recruiting USA 0
NCT02666950 Phase II Adavosertib Cytarabine WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed USA 0
NCT02488408 Phase I Cytarabine Bemcentinib Multicenter Open-label Study of BGB324 as a Single Agent and in Combination With Cytarabine in Patients With AML Active, not recruiting USA 3
NCT02756962 Phase II Midostaurin Cytarabine Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance Recruiting USA 0
NCT03900949 Phase I Midostaurin Cytarabine Cytarabine + Gemtuzumab ozogamicin Cytarabine + Daunorubicin + Gemtuzumab ozogamicin Testing the Combination of Standard Induction Therapy With Gemtuzumab Ozogamicin and Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia Suspended USA 0
NCT02907359 Phase III Cytarabine Guadecitabine Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs Completed USA | CAN 12
NCT03164057 Phase II Etoposide Filgrastim Dexrazoxane Daunorubicin Idarubicin Fludarabine Asparaginase Cytarabine Sorafenib Mitoxantrone Decitabine Azacitidine A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia Recruiting USA 0
NCT02573363 Phase I Cytarabine Mitoxantrone Selinexor Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia Completed USA 0
NCT02421939 Phase III Cytarabine Cytarabine + Fludarabine + Idarubicin Cytarabine + Etoposide + Mitoxantrone Azacitidine Gilteritinib Filgrastim A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation Active, not recruiting USA | CAN 12
NCT01614197 Phase I Etoposide Cyclophosphamide Prednisone Cytarabine Temsirolimus Methotrexate A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma Completed USA | CAN 1
NCT03836209 Phase II Cytarabine + Daunorubicin + Gilteritinib Cytarabine + Daunorubicin + Midostaurin Cytarabine Midostaurin Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia Recruiting USA 0
NCT03020030 Phase III Nelarabine Dexrazoxane Asparaginase Vincristine Sulfate Cyclophosphamide Cytarabine Mercaptopurine Pegaspargase Methotrexate Etoposide Doxorubicin Dexamethasone Prednisone Dasatinib Leucovorin Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents Recruiting USA | CAN 0
NCT02212561 Phase Ib/II Selinexor Cytarabine Cytarabine + Dexamethasone + Methotrexate Fludarabine Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome Completed USA 0
NCT02351037 Phase II Ibrutinib Cytarabine A Multicenter Open-Label Phase 2a Study of Ibrutinib With or Without Cytarabine in Subjects With Acute Myeloid Leukemia Terminated USA 0
NCT01794702 Phase Ib/II Idarubicin Clofarabine Cytarabine Decitabine Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia Completed USA 0
NCT02412475 Phase I Cytarabine Sorafenib Vorinostat Filgrastim Daunorubicin Fludarabine Decitabine Epigenetic Reprogramming in Relapse AML Terminated USA 0
NCT03591510 Phase II Cytarabine Cytarabine + Etoposide Cytarabine + Mitoxantrone Cytarabine + Fludarabine + Idarubicin Cytarabine + Daunorubicin + Fludarabine Cytarabine + Daunoxome + Fludarabine Midostaurin A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML Recruiting USA 9
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 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 Recruiting USA 0
NCT02560025 Phase II Alisertib Daunorubicin Idarubicin Cytarabine Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML Completed USA 0
NCT03263936 Phase I Vorinostat Decitabine Cytarabine Fludarabine Filgrastim Epigenetic Reprogramming in Relapse/Refractory AML Active, not recruiting USA | CAN 1
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Completed USA 0
NCT02553460 Phase II Cyclophosphamide Mitoxantrone Dexamethasone Bortezomib Etoposide Vincristine Sulfate Pegaspargase Vorinostat Cytarabine Methotrexate Leucovorin Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I Recruiting USA | CAN 0
NCT02003222 Phase III Cytarabine Daunorubicin + Dexamethasone + Methotrexate + Pegaspargase + Vincristine Sulfate Mercaptopurine + Methotrexate + Prednisone + Vincristine Sulfate Cyclophosphamide + Cytarabine + Mercaptopurine + Pegaspargase Methotrexate + Pegaspargase Cytarabine + Etoposide + Methotrexate Rituximab Blinatumomab Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia Active, not recruiting USA | CAN 2
NCT04229979 Phase III Galinpepimut-S Cytarabine Decitabine Venetoclax Azacitidine GPS Compared With BAT in AML CR2/CR2p Recruiting USA 0
NCT03860844 Phase II Idarubicin Cyclophosphamide Isatuximab Doxorubicin Etoposide Daunoxome Cytarabine Methotrexate Daunorubicin Fludarabine Dexamethasone Mitoxantrone Filgrastim Vincristine Sulfate Pegaspargase Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia Recruiting USA | CAN 18
NCT01321346 Phase I Cytarabine Panobinostat A Study Of Panobinostat In Children With Refractory Hematologic Malignancies Completed USA 0
NCT02112916 Phase III Cyclophosphamide Vincristine Sulfate Ifosfamide Pegaspargase Methotrexate Cytarabine Mercaptopurine Thioguanine Leucovorin Daunorubicin Dexamethasone Bortezomib Etoposide Doxorubicin 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 Active, not recruiting USA | CAN 2
NCT03194932 Phase I Cytarabine Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia Recruiting USA 0
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Active, not recruiting USA 0
NCT02348489 Phase III Guadecitabine Cytarabine Azacitidine Decitabine SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction Completed USA | CAN 22
NCT02545283 Phase III Cytarabine Cytarabine + Idasanutlin A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia Terminated USA | CAN 17
NCT02532192 Phase I Rituximab Cisplatin Dexamethasone Cytarabine Fluconazole Belinostat A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma Withdrawn 0
NCT02724163 Phase III Gemtuzumab ozogamicin Busulfan + Fludarabine Cytarabine Cytarabine + Fludarabine Cytarabine + Daunoxome Busulfan + Cyclophosphamide Cytarabine + Mitoxantrone International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia (Myechild01) Recruiting 6
NCT02521493 Phase III Etoposide Thioguanine Cytarabine Asparaginase Erwinia chrysanthemi mitoxantrone hydrochloride Daunorubicin Asparaginase Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome Recruiting USA | CAN 4
NCT02883049 Phase III Dasatinib Dexamethasone + Doxorubicin Prednisone Vincristine Sulfate Thioguanine Cytarabine Mercaptopurine Leucovorin Methotrexate Pegaspargase Etoposide Clofarabine Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations Active, not recruiting USA | CAN 5
NCT03007147 Phase III Pegaspargase Methotrexate Leucovorin Cytarabine Mercaptopurine Thioguanine Vincristine Sulfate Cyclophosphamide Imatinib Ifosfamide Dexrazoxane Daunorubicin Dexamethasone Methylprednisolone Etoposide Prednisolone Doxorubicin Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Recruiting USA | CAN 17
NCT03147612 Phase II Pegfilgrastim Blinatumomab Vincristine Sulfate Rituximab Filgrastim Ponatinib Cyclophosphamide Methotrexate Cytarabine Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia Recruiting USA 0
NCT02881086 Phase III Rituximab Doxorubicin Cytarabine Mercaptopurine Nelarabine Methotrexate Pegaspargase Cyclophosphamide Vindesine Vincristine Sulfate Daunorubicin Dexamethasone Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment Recruiting 1
NCT02088541 Phase II Cytarabine Azacitidine Decitabine Selinexor Hydroxyurea Selinexor (KPT-330) in Older Patients With Relapsed AML Completed USA | CAN 9
NCT03813147 Phase I Azacitidine + Cytarabine + Fludarabine + MLN4924 Cytarabine Cytarabine + Hydrocortisone + Methotrexate Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome Active, not recruiting USA 0
NCT03962465 Phase I Daunorubicin + Inotuzumab ozogamicin + Pegaspargase + Prednisone + Vincristine Sulfate Daunorubicin + Inotuzumab ozogamicin + Prednisone + Vincristine Sulfate Cytarabine Methotrexate Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Younger Adults With Relapsed/Refractory B-cell ALL (ALL 001) Recruiting USA 0
NCT03926624 Phase III Decitabine + Venetoclax Azacitidine + Venetoclax Cytarabine + Filgrastim + Fludarabine + Idarubicin Cytarabine + Venetoclax Cytarabine + Filgrastim + Fludarabine Decitabine Azacitidine Cladribine + Cytarabine + Filgrastim + Mitoxantrone DFP-10917 Cladribine + Cytarabine + Filgrastim + Idarubicin Cytarabine Cytarabine + Etoposide + Mitoxantrone Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage Recruiting USA 0


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