Therapy Detail

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Therapy Name Romidepsin
Synonyms
Therapy Description

Istodax (romidepsin) inhibits Class I HDACs, resulting in cell cycle arrest, apoptosis, and decreased tumor cell growth (PMID: 12208741, PMID: 12234611, PMID: 21258344). Istodax (romidepsin) is FDA approved for patients with cutaneous T-cell lymphoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Romidepsin Istodax FK228|FR901228|NSC 630176|depsipeptide HDAC Inhibitor 45 Istodax (romidepsin) inhibits Class I HDACs, resulting in cell cycle arrest, apoptosis, and decreased tumor cell growth (PMID: 12208741, PMID: 12234611, PMID: 21258344). Istodax (romidepsin) is FDA approved for patients with cutaneous T-cell lymphoma (FDA.gov).

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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 decreased response Romidepsin Preclinical - Cell line xenograft Actionable In a preclinical study, Istodax (romidepsin) resulted in minimal activity in acute lymphocytic leukemia cell lines harboring a KMT2A rearrangement in culture, and in cell line xenograft models, demonstrating decreased leukemic cells by 16% (PMID: 27443263). 27443263

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 Completed USA 0
NCT02512497 Phase I Romidepsin Busulfan + Fludarabine + Romidepsin Romidepsin Maintenance After Allogeneic Stem Cell Transplantation Active, not recruiting USA 0
NCT04747236 Phase II Pralatrexate Belinostat Azacitidine + Romidepsin Gemcitabine Romidepsin A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in Patients With Relapse or Refractory Peripheral T-cell Lymphoma (PTCL) Recruiting USA 0
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
NCT01638533 Phase I Romidepsin Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Active, not recruiting USA | CAN 0
NCT02181218 Phase I Pegfilgrastim Romidepsin Dexamethasone + Gemcitabine + Oxaliplatin Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas Completed USA 0
NCT01897012 Phase I Romidepsin Alisertib Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas Completed USA 0
NCT03278782 Phase Ib/II Romidepsin Pembrolizumab + Romidepsin Study of Pembrolizumab (MK-3475) in Combination With Romidepsin Active, not recruiting USA 0
NCT03432741 Phase I Carfilzomib Daratumumab Obinutuzumab Gemcitabine Trastuzumab Romidepsin Nivolumab Rituximab Belinostat Pembrolizumab Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer Suspended USA 0
NCT04774068 Phase I Romidepsin Parsaclisib + Romidepsin Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas Active, not recruiting USA 0


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