Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Weiyun Ai

Description

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.

Official Title

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

Keywords

T Cell Lymphoma RP6530 Tenalisib Romidepsin Lymphoma Lymphoma, T-Cell Tenalisib+Romidepsin

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Pathologically confirmed T-cell lymphomas at the enrolling institution.
  2. Disease status as defined as relapsed or progressed patients who have received at least one systemic therapy.
  3. The patients should have received NOT more than three prior systemic combination chemotherapies
  4. 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.
  5. Must have ECOG performance status ≤ 2
  6. Adequate bone marrow, liver and renal function in line with below mentioned laboratory requirements.
  7. Hemoglobin ≥8.0 g/dL
  8. Absolute neutrophil count (ANC) ≥1,000/µL
  9. Platelet count ≥75,000/μL
  10. Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
  11. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN in case of liver involvement
  12. Calculated creatinine clearance (CrCl) > 50 ml/min by Cockcroft-Gault formula
  13. Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential.
  14. Provide written informed consent prior to any study-specific screening procedures.
  15. Willingness and capability to comply with the requirements of the study

You CAN'T join if...

  1. Patient receiving anticancer therapy including any investigational therapy ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1.
  2. Patient who discontinued prior therapy with PI3K inhibitors or HDAC inhibitors due to drug toxicity.
  3. 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.
  4. Patient with medical conditions requiring the use of systemic immunosuppressive medications (> 20 mg/day of prednisone or equivalent).
  5. Severe bacterial, viral or mycotic infection requiring systemic treatment.
  6. Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV) infection.
  7. 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..
  8. Known seropositive requiring anti-viral therapy for hepatitis c virus (HCV) infection OR patients with positive hepatitis C virus Ab.
  9. 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.
  10. . 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.
  11. . Uncontrolled or significant cardiovascular disease including, but not limited to:
  12. Congenital long QT syndrome.
  13. QTcF interval > 450 msec
  14. Myocardial infarction or stroke/TIA within the past 6 months
  15. Uncontrolled angina within the past 3 months
  16. Significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block (AV) block type II, 3rd degree AV block.
  17. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes),
  18. History of other clinically significant heart disease (ie, cardiomyopathy, congestive heart failure with NYHA functional classification III-IV, pericarditis, significant pericardial effusion)
  19. Requirement for daily supplemental oxygen therapy.

Locations

  • 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

  • Weiyun Ai
    Professor, Medicine. Authored (or co-authored) 43 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rhizen Pharmaceuticals SA
ID
NCT03770000
Phase
Phase 1/2
Study Type
Interventional
Last Updated