^
    6d
    PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=89, Completed, Fondazione Italiana Linfomi - ETS | Active, not recruiting --> Completed
    Trial completion
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • prednisone • Istodax (romidepsin)
    6d
    Targeting histone deacetylation, cell cycle regulators and heat shock proteins as novel therapeutic strategies for penile cancers. (PubMed, NPJ Precis Oncol)
    A paclitaxel, ifosfamide, and cisplatin-based regimen achieves response rates around 65%...Compared to standard chemotherapy (e.g. cisplatin, 5-FU, ifosfamide, irinotecan), treatment with romidepsin, quisinostat (HDAC inhibitors (i)), palbociclib (CDK4/6i), or 17-AAG and PU-H71 (HSP90i) reduced cell viability, induced apoptosis, and led to G2 / M cell cycle arrest in most PeCa cells. This research underscores the therapeutic potential of using HDAC, CDK4/6, and HSP90 inhibitors for PeCa management and reveals additional promising targets and biomarkers for future strategies.
    Journal
    |
    HIF1A (Hypoxia inducible factor 1, alpha subunit)
    |
    cisplatin • Ibrance (palbociclib) • paclitaxel • 5-fluorouracil • ifosfamide • irinotecan • Istodax (romidepsin) • quisinostat (JNJ 26481585) • zelavespib intravenous (PU-H71 IV)
    29d
    Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents (clinicaltrials.gov)
    P1, N=12, Suspended, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Suspended
    Trial suspension
    |
    Imfinzi (durvalumab) • Istodax (romidepsin)
    2ms
    Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies (clinicaltrials.gov)
    P1, N=26, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Dec 2025
    Trial completion • Trial completion date
    |
    TNFRSF8 positive
    |
    lenalidomide • dexamethasone • Istodax (romidepsin) • Onureg (azacitidine oral)
    2ms
    SYNACTHIV: Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load (clinicaltrials.gov)
    P1, N=9, Completed, ANRS, Emerging Infectious Diseases | Recruiting --> Completed | N=15 --> 9 | Trial completion date: Apr 2026 --> Dec 2025 | Trial primary completion date: Apr 2026 --> Dec 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    decitabine • Istodax (romidepsin)
    3ms
    EPI-SauriCas9-based mouse ovarian cancer models recapitulating pten deletion in patients. (PubMed, Commun Biol)
    High-throughput drug screening identifies FK228 and thioguanine as promising therapeutic candidates, both of which show in vivo efficacy and are validated in PTEN-deleted organoids. Together, these results establish MEPP as a platform for studying PTEN-deleted ovarian cancer and provide a strategy for generating clinically relevant tumor models through targeted gene editing.
    Preclinical • Journal
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog)
    |
    TP53 mutation • PTEN deletion • TP53 deletion
    |
    Istodax (romidepsin) • thioguanine
    3ms
    In Vitro and In Vivo Efficacy of Romidepsin Alone and in Addition to Standard of Care for Treatment of Ewing Sarcoma. (PubMed, Cancers (Basel))
    In vitro we identified that romidepsin synergizes with doxorubicin and etoposide and that it increases the efficacy of the standard of care combinations VDC/IE. In vivo, the combination of romidepsin and ifosfamide/etoposide (IE) leads to a significant decrease in tumor volume compared to that of IE alone. Our data indicates that romidepsin improves efficacy of chemotherapeutic agents in vitro and leads to a decreased tumor volume in vivo, suggesting that the addition of romidepsin may improve upfront treatment in ES patients.
    Preclinical • Journal
    |
    CASP3 (Caspase 3) • CASP7 (Caspase 7)
    |
    doxorubicin hydrochloride • ifosfamide • etoposide IV • Istodax (romidepsin)
    6ms
    Combined HDAC and eIF4A inhibition: A novel epigenetic therapy for pancreatic ductal adenocarcinoma. (PubMed, Drug Resist Updat)
    In this work, we discovered that the combination of class I histone deacetylase (HDAC) inhibitors, such as romidepsin, with a novel RNA helicase eIF4A inhibitor, des-methyl pateamine A (DMPatA), induces robust and persistent hyperacetylation, significantly exceeding the levels and duration observed with HDAC inhibitor monotherapy...The combination does not appear to induce known resistance mechanisms such as drug efflux; elevated MYC expression, rather than inducing resistance, sensitizes PDAC cells to treatment. These studies support translation of this synergistic combination to the clinic.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • MYC (V-myc avian myelocytomatosis viral oncogene homolog)
    |
    Istodax (romidepsin)
    6ms
    A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=47, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Oct 2025 | Trial primary completion date: Jul 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    cytarabine • etoposide IV • carmustine • Istodax (romidepsin) • melphalan
    6ms
    The noncanonical function of liver-type phosphofructokinase potentiates the efficacy of HDAC inhibitors in cancer. (PubMed, Signal Transduct Target Ther)
    Based on the mechanism of PFKL facilitates the efficacy of romidepsin, we developed a therapeutic peptide, PFKL-552-572-R8, which significantly enhances the antitumor effect of romidepsin both in vitro and in vivo. Our findings reveal that spatiotemporal regulation confers a moonlight function to PFKL as an endogenous HDAC inhibitor to maintain the stability of epigenetic modifications and highlight PFKL as a promising therapeutic target for enhancing the clinical utility of HDACi in solid tumors.
    Journal
    |
    PFKL (Phosphofructokinase, Liver Type)
    |
    Istodax (romidepsin)
    6ms
    Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P1/2, N=51, Active, not recruiting, Priyanka Sharma | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    Opdivo (nivolumab) • cisplatin • Istodax (romidepsin)
    6ms
    SEPION: Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=75, Completed, GWT-TUD GmbH | Active, not recruiting --> Completed
    Trial completion
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Imfinzi (durvalumab) • gemcitabine • lenalidomide • azacitidine • albumin-bound paclitaxel • Istodax (romidepsin)