Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.
An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma
T Cell Lymphoma RP6530 Tenalisib Romidepsin Lymphoma Lymphoma, T-Cell Tenalisib+Romidepsin
You can join if…
Open to people ages 18 years and up
- Pathologically confirmed T-cell lymphomas at the enrolling institution.
- Disease status as defined as relapsed or progressed patients who have received at least one systemic therapy.
- The patients should have received NOT more than three prior systemic combination chemotherapies
- PTCL patients must have measurable disease defined as at least one bidimensional measurable lesion with minimum measurement of > 1.5 cm in the longest diameter.
- Must have ECOG performance status ≤ 2
- Adequate bone marrow, liver and renal function in line with below mentioned laboratory requirements.
- Hemoglobin ≥8.0 g/dL
- Absolute neutrophil count (ANC) ≥1,000/µL
- Platelet count ≥75,000/μL
- Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
- AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN in case of liver involvement
- Calculated creatinine clearance (CrCl) > 50 ml/min by Cockcroft-Gault formula
- Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential.
- Provide written informed consent prior to any study-specific screening procedures.
- Willingness and capability to comply with the requirements of the study
You CAN'T join if...
- Patient receiving anticancer therapy including any investigational therapy ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1.
- Patient who discontinued prior therapy with PI3K inhibitors or HDAC inhibitors due to drug toxicity.
- PTCL patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1. CTCL patients with the history of Allo-SCT will be excluded.
- Patient with medical conditions requiring the use of systemic immunosuppressive medications (> 20 mg/day of prednisone or equivalent).
- Severe bacterial, viral or mycotic infection requiring systemic treatment.
- Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV) infection.
- Known seropositive requiring anti-viral therapy for hepatitis B virus (HBV) infection OR evidence of active hepatitis B infection as defined by detectable viral load if the antibody tests are positive..
- Known seropositive requiring anti-viral therapy for hepatitis c virus (HCV) infection OR patients with positive hepatitis C virus Ab.
- Subjects with active EBV unrelated to underlying lymphoma (positive serology for anti-EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection.
- . Subject with active CMV (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody and positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy.
- . Uncontrolled or significant cardiovascular disease including, but not limited to:
- Congenital long QT syndrome.
- QTcF interval > 450 msec
- Myocardial infarction or stroke/TIA within the past 6 months
- Uncontrolled angina within the past 3 months
- Significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block (AV) block type II, 3rd degree AV block.
- History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes),
- History of other clinically significant heart disease (ie, cardiomyopathy, congestive heart failure with NYHA functional classification III-IV, pericarditis, significant pericardial effusion)
- Requirement for daily supplemental oxygen therapy.
- University of California, Hellen Diller Family Comprehensive Cancer Center
accepting new patients
San Francisco California 94143 United States
- Oregon Health & Science University
accepting new patients
Portland Oregon 97239 United States
Lead Scientist at UCSF
- Weiyun Ai
Professor, Medicine. Authored (or co-authored) 43 research publications
- accepting new patients
- Start Date
- Completion Date
- Rhizen Pharmaceuticals SA
- Phase 1/2
- Study Type
- Last Updated
Please contact me about this study
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03770000.