Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory 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
1 other identifier
interventional
33
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2019
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 10, 2018
CompletedStudy Start
First participant enrolled
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2021
CompletedResults Posted
Study results publicly available
October 28, 2022
CompletedOctober 28, 2022
October 1, 2022
2.2 years
December 6, 2018
May 4, 2022
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With and Without Dose Limiting Toxicities (DLTs)
The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
28 days
Secondary Outcomes (3)
Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination
12 weeks
Duration of Response (DoR) With Tenalisib and Romidepsin Combination
28 weeks
Maximum Observed Plasma Concentration (Cmax)
8 days
Study Arms (1)
Tenalisib+Romidepsin
EXPERIMENTALParticipants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
Interventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Rush University Cancer Center
Chicago, Illinois, 60612, United States
The University of Kansas Cancer Center
Fairway, Kansas, 66205, United States
Norton Cancer Institute, St Matthews Campus
Louisville, Kentucky, 40207, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232-5505, United States
The University of Texas MD Anderson Cancer Center,
Houston, Texas, 77030, United States
Related Publications (1)
Iyer SP, Huen A, Ai WZ, Jagadeesh D, Lechowicz MJ, Okada C, Feldman TA, Ghione P, Alderuccio JP, Champion R, Kim SH, Mohrbacher A, Routhu KV, Barde P, Nair AM, Haverkos BM. Safety and efficacy of tenalisib in combination with romidepsin in patients with relapsed/refractory T-cell lymphoma: results from a phase I/II open-label multicenter study. Haematologica. 2024 Jan 1;109(1):209-219. doi: 10.3324/haematol.2022.281875.
PMID: 37439343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ajit Nair
- Organization
- Rhizen Pharmaceuticals AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2018
First Posted
December 10, 2018
Study Start
March 12, 2019
Primary Completion
May 14, 2021
Study Completion
May 14, 2021
Last Updated
October 28, 2022
Results First Posted
October 28, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share