Therapy Detail

Therapy Name Romidepsin
Therapy Description


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Drug Name Trade Name Synonyms Drug Classes Drug Description
Romidepsin Istodax FK228|FR901228|NSC 630176|depsipeptide HDAC Inhibitor 35 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 (
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KMT2A rearrange acute lymphocytic 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
Unknown unknown Advanced Solid Tumor not applicable Romidepsin Phase I Actionable In a Phase I trial, Istodax (romidepsin), in combination with Gemzar (gemcitabine), demonstrated safety and some efficacy in patients with a variety of advanced solid tumors (J Clin Oncol, May 2008 vol. 26 no. 15_suppl 2567). detail...
Unknown unknown cutaneous T cell lymphoma not applicable Romidepsin FDA approved Actionable In clinical trials that supported FDA approval, treatment with Istodax (romidepsin) produced a 35% (34/96) response rate in patients with cutaneous T cell lymphoma (PMID: 20697094). 20697094
Clinical Trial Phase Therapies Title Recruitment Status
NCT02512497 Phase I Romidepsin Busulfan + Fludarabine + Romidepsin Romidepsin Maintenance After Allogeneic Stem Cell Transplantation Recruiting
NCT02181218 Phase I Pegfilgrastim Romidepsin Dexamethasone + Gemcitabine + Oxaliplatin Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas Active, not recruiting
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 Recruiting
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 Recruiting
NCT01897012 Phase I Romidepsin Alisertib Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas Completed
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 Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Recruiting
NCT01638533 Phase I Romidepsin Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Active, not recruiting
NCT03278782 Phase Ib/II Romidepsin Pembrolizumab + Romidepsin Study of Pembrolizumab (MK-3475) in Combination With Romidepsin Recruiting