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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
NCT02512497	Phase I	Romidepsin Busulfan + Fludarabine + Romidepsin	Romidepsin Maintenance After Allogeneic Stem Cell Transplantation	Active, not recruiting	USA	0
NCT03278782	Phase Ib/II	Romidepsin Pembrolizumab + Romidepsin	Study of Pembrolizumab (MK-3475) in Combination With Romidepsin	Active, not recruiting	USA	0
NCT01638533	Phase I	Romidepsin	Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction	Completed	USA \| CAN	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
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
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
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
NCT04774068	Phase I	Romidepsin Parsaclisib + Romidepsin	Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas	Completed	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
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	Terminated	USA	0

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