Status:
COMPLETED
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
Lead Sponsor:
Rhizen Pharmaceuticals SA
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03770000
Start Date
March 12 2019
End Date
May 14 2021
Last Update
October 28 2022
Active Locations (15)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
4
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136