Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
NCT ID: NCT03770000
Last Updated: 2022-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2019-03-12
2021-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tenalisib+Romidepsin
Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
Tenalisib
Tenalisib, BID orally daily
Romidepsin
Romidepsin IV
Interventions
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Tenalisib
Tenalisib, BID orally daily
Romidepsin
Romidepsin IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
1. Hemoglobin ≥8.0 g/dL
2. Absolute neutrophil count (ANC) ≥1,000/µL
3. Platelet count ≥75,000/μL
4. Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
5. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN in case of liver involvement
6. Calculated creatinine clearance (CrCl) \> 50 ml/min by Cockcroft-Gault formula
7. Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential.
8. Provide written informed consent prior to any study-specific screening procedures.
9. Willingness and capability to comply with the requirements of the study
Exclusion Criteria
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:
* 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.
18 Years
ALL
No
Sponsors
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Rhizen Pharmaceuticals SA
INDUSTRY
Responsible Party
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Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Rush University Cancer Center
Chicago, Illinois, United States
The University of Kansas Cancer Center
Fairway, Kansas, United States
Norton Cancer Institute, St Matthews Campus
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center,
Houston, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RP6530+Romidepsin-1805
Identifier Type: -
Identifier Source: org_study_id
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