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1m
Phase II Study Evaluating the Combination of Linperlisib, Azacitidine, and Liposomal Mitoxantrone in Treatment-Naïve Nodal TFH Cell Lymphoma (ChiCTR2500107944)
P2, N=30, Not yet recruiting, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University
New P2 trial
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azacitidine • Zepsun (donafenib) • Itari (linperlisib) • Duoenda (mitoxantrone liposomal)
2ms
New P1/2 trial
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Tazverik (tazemetostat) • Itari (linperlisib) • golidocitinib (DZD4205)
3ms
New P1/2 trial
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Epidaza (chidamide) • Itari (linperlisib)
4ms
New trial
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azacitidine • Itari (linperlisib)
4ms
Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia (clinicaltrials.gov)
P2, N=41, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Trial completion date: Oct 2025 --> Jan 2026 | Trial primary completion date: Jun 2025 --> Oct 2025
Trial completion date • Trial primary completion date
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Itari (linperlisib)
5ms
Linperlisib Plus Chidamide in Relapsed or Refractory Cutaneous T-Cell Lymphoma: A Nonrandomized Clinical Trial. (PubMed, JAMA Dermatol)
This all-oral combination may represent a new therapeutic option for advanced CTCL, particularly in mycosis fungoides. ClinicalTrials.gov Identifier: NCT06037239.
Clinical • Journal
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PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
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Epidaza (chidamide) • Itari (linperlisib)
6ms
Successful treatment of an elderly patient with relapsed/refractory angioimmunoblastic T-cell lymphoma with the PI3Kδ inhibitor linperlisib: a Case Report. (PubMed, Front Pharmacol)
We present the case of an 80-year-old woman with relapsed/refractory (R/R) AITL who relapsed after CHOP and exhibited resistance to the following sequential therapies: second-line chidamide plus COP and third-line chidamide with mitoxantrone hydrochloride liposome...Salvage therapy with linperlisib, a selective PI3Kδ inhibitor, combined with gemcitabine/oxaliplatin induced sustained partial remission, followed by linperlisib maintenance...This case highlights the dual role of linperlisib as an effective and well-tolerated therapy for elderly R/R AITL patients who have exhausted prior lines. By precisely targeting PI3Kδ, our findings offer critical real-world evidence to address the unmet need for safe salvage strategies in this vulnerable population.
Journal
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IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • DNMT3A (DNA methyltransferase 1) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
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IDH2 mutation
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gemcitabine • oxaliplatin • Epidaza (chidamide) • Itari (linperlisib) • Duoenda (mitoxantrone liposomal)
8ms
KLRG1 re-defines a leukemic clone of CD8 effector T cells sensitive to PI3K inhibitor in T cell large granular lymphocytic leukemia. (PubMed, Cell Rep Med)
In a pilot trial of linperlisib (a PI3Kδ inhibitor) for refractory cases, 7 of 8 participants quickly respond with satisfactory safety. This study is registered at ClinicalTrials.gov (NCT05676710).
Journal
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CD8 (cluster of differentiation 8) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • KLRG1 (Killer Cell Lectin Like Receptor G1)
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Itari (linperlisib)
9ms
Enrollment open
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Tyvyt (sintilimab) • Itari (linperlisib)
10ms
Chidamide Combined With Linperlisibon for the Treatment of Refractory/Relapsed Follicular Lymphoma (clinicaltrials.gov)
P2, N=33, Recruiting, The First Affiliated Hospital of Xiamen University | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2027
Trial completion date • Trial primary completion date
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Epidaza (chidamide) • Itari (linperlisib)
10ms
PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial. (PubMed, Cancer Cell Int)
This study highlights the potential of linperlisib plus GEMOX as a treatment for R/R DLBCL, demonstrating a tolerable safety profile and encouraging efficacy results.
P1/2 data • Journal
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PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
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gemcitabine • oxaliplatin • Itari (linperlisib)
10ms
New P1 trial
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Tyvyt (sintilimab) • Itari (linperlisib)