^
    4d
    Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=17, Terminated, Washington University School of Medicine | Active, not recruiting --> Terminated; Loss of funding
    Trial termination
    |
    Copiktra (duvelisib)
    11d
    Tet2 deficiency alters CD4+ T cell function and promotes T cell lymphoma with a TFH cell immunophenotype. (PubMed, J Exp Med)
    scRNA-seq revealed a persistent proliferative cluster characterized by elevated stem-like transcriptional features compared with WT counterparts. Tet2-/- m-TCLs allografted into NSG mice showed a significant response to epigenetic (5-azacytidine) and PI3K inhibitors (duvelisib) alone or in combination.
    Journal • IO biomarker
    |
    TET2 (Tet Methylcytosine Dioxygenase 2) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    TET2 mutation
    |
    azacitidine • Copiktra (duvelisib)
    16d
    Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas (clinicaltrials.gov)
    P1, N=114, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed
    Trial completion
    |
    bortezomib • Copiktra (duvelisib) • Istodax (romidepsin)
    17d
    Duvelisib Induces Deep Responses in PTCL: Final Results of the Phase 2 PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma. (PubMed, J Clin Oncol)
    The PRIMO study demonstrates significant activity and tolerability of duvelisib in patients with R/R PTCL, most notably in the AITL subgroup. This provides strong rationale for further development in PTCL, and more specifically in the subgroup of nodal T-follicular helper cell lymphoma.
    P2 data • Journal
    |
    PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)
    |
    Copiktra (duvelisib)
    1m
    A051902: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma (clinicaltrials.gov)
    P2, N=170, Suspended, Alliance for Clinical Trials in Oncology | Trial completion date: Jun 2026 --> May 2027 | Trial primary completion date: Jun 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    PD-1 (Programmed cell death 1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BCL6 (B-cell CLL/lymphoma 6) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • ICOS (Inducible T Cell Costimulator) • MME (Membrane Metalloendopeptidase)
    |
    TNFRSF8 expression
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • Copiktra (duvelisib) • vincristine • prednisone • Onureg (azacitidine oral)
    1m
    Emerging Therapeutic Strategies in Cutaneous T-Cell Lymphoma: A Comprehensive Review of Clinical Trials. (PubMed, Am J Clin Dermatol)
    The 2020-2025 period brought meaningful therapeutic advances for CTCL, including new FDA approvals, breakthrough designations, and emergence of cellular therapy. Future development should prioritize patient-reported outcomes as co-primary endpoints, prospective biomarker validation, and combination strategies with non-overlapping toxicity profiles.
    Review • Journal • IO biomarker
    |
    CD70 (CD70 Molecule)
    |
    Copiktra (duvelisib) • tenalisib (RP6530) • Ontak (denileukin diftitox) • Itari (linperlisib) • Lymphir (denileukin diftitox-cxdl) • CTX130 • HyBryte (synthetic hypericin) • lacutamab (IPH4102)
    1m
    A phase I/II Study of Duvelisib plus Venetoclax in Patients with Relapsed/Refractory CLL/SLL or Richter Transformation. (PubMed, Blood Adv)
    Overall, duvelisib plus venetoclax was active in high-risk R/R CLL/SLL and RT, though serious adverse events occurred, including immune-mediated toxicities. NCT03534323.
    P1/2 data • Journal
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    Venclexta (venetoclax) • Copiktra (duvelisib)
    3ms
    Cutaneous and Systemic Complications in Primary CD8+ Aggressive Epidermotropic Cytotoxic T-cell Lymphoma. (PubMed, Cureus)
    We present the case of a 61-year-old man with CD8+ AECTCL who developed a methicillin-sensitive Staphylococcus aureus port-site infection while on duvelisib following prior gemcitabine/liposomal doxorubicin therapy...Complement studies supported the activation of the alternative pathway, and after multidisciplinary discussion, eculizumab was initiated for TMA management...His cutaneous lymphoma lesions improved with a short course of oral prednisone as directed by oncology. At discharge, he was clinically stable on dialysis with plans for ongoing outpatient care; subsequent follow-up showed stable renal function. This case highlights the intersection between aggressive cutaneous lymphoma, infection, and chemotherapy-induced vascular injury, emphasizing the importance of early recognition of systemic complications in CD8+ AECTCL and the need for a multidisciplinary approach to optimize patient outcomes.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Copiktra (duvelisib) • prednisone
    4ms
    Human Serum Albumin-Lipid Nanocapsules of Duvelisib for Hematological Cancers: Characterization, In-Vitro Cell-Culture, Toxicity and Pharmacokinetic Studies. (PubMed, AAPS PharmSciTech)
    The DUV-NCs were found to be safe in toxicity studies with no major alterations in biomarkers compared to the control. In conclusion, DUV-NCs is a promising strategy to deliver DUV in hematological malignancies with improved efficacy and safety.
    PK/PD data • Preclinical • Journal
    |
    PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)
    |
    Copiktra (duvelisib)
    4ms
    Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2025 --> Oct 2026
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14)
    |
    Copiktra (duvelisib) • ETP-47187
    4ms
    Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Dec 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    Copiktra (duvelisib)
    5ms
    Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (clinicaltrials.gov)
    P1, N=38, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2027 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Copiktra (duvelisib) • ABP 206 (nivolumab biosimilar) • ETP-47187