Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed / Refractory T-cell Lymphoma
Trial Status: Active
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.
- 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
- 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.
USC / Norris Comprehensive Cancer Center
Contact: Christine Duran
UCSF Medical Center-Mount Zion
Contact: UCSF Clinical Trials
University of Colorado Hospital
University of Miami Miller School of Medicine-Sylvester Cancer Center
Emory University Hospital / Winship Cancer Institute
University of Kansas Cancer Center
Contact: Adam Hisham Al Douri
University of Michigan Comprehensive Cancer Center
Roswell Park Cancer Institute
Case Comprehensive Cancer Center
OHSU Knight Cancer Institute
Vanderbilt University / Ingram Cancer Center
M D Anderson Cancer Center
Trial Phase Phase I/II
Trial Type Treatment
Rhizen Pharmaceuticals SA
- Primary ID RP6530+Romidepsin-1805
- Secondary IDs NCI-2019-01885
- Clinicaltrials.gov ID NCT03770000