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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.

Inclusion Criteria

  • 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 Criteria

  • 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.

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Christine Duran
Phone: 323-865-0371
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Adam Hisham Al Douri
Phone: 913-945-7547

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Rhizen Pharmaceuticals SA

  • Primary ID RP6530+Romidepsin-1805
  • Secondary IDs NCI-2019-01885
  • Clinicaltrials.gov ID NCT03770000