Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03770000 |
Recruitment Status :
Active, not recruiting
First Posted : December 10, 2018
Last Update Posted : November 10, 2020
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Condition or disease | Intervention/treatment | Phase |
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T Cell Lymphoma | Drug: Tenalisib Drug: Romidepsin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 12, 2019 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | November 2021 |

Arm | Intervention/treatment |
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Experimental: Tenalisib+Romidepsin
Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
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Drug: Tenalisib
Tenalisib, BID orally daily
Other Name: RP6530 Drug: Romidepsin Romidepsin IV |
- Maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in Patients with T cell lymphoma [ Time Frame: 28 days ]The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment
- Overall response rate (ORR) with Tenalisib and Romidepsin combination [ Time Frame: 12 weeks ]No. of patients with partial and complete response
- Duration of Response (DoR) with Tenalisib and Romidepsin combination [ Time Frame: 12 weeks ]The time period from the response achieved in patient until the disease progression
- Maximum observed plasma concentration (Cmax) [ Time Frame: 8 days ]Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770000
United States, California | |
USC/Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 | |
University of California, Hellen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
University of Colorado Cancer Center | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
University of Miami-Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Rush University Cancer Center | |
Chicago, Illinois, United States, 60612 | |
United States, Kansas | |
The University of Kansas Cancer Center | |
Fairway, Kansas, United States, 66205 | |
United States, Kentucky | |
Norton Cancer Institute, St Matthews Campus | |
Louisville, Kentucky, United States, 40207 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New Jersey | |
John Theurer Cancer Center, Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Roswell Park Comprehensive Cancer Center | |
Buffalo, New York, United States, 14263 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Institute | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-5505 | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center, | |
Houston, Texas, United States, 77030 |
Responsible Party: | Rhizen Pharmaceuticals SA |
ClinicalTrials.gov Identifier: | NCT03770000 |
Other Study ID Numbers: |
RP6530+Romidepsin-1805 |
First Posted: | December 10, 2018 Key Record Dates |
Last Update Posted: | November 10, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
T cell Lymphoma RP6530 Tenalisib Romidepsin |
Lymphoma Lymphoma, T-Cell Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Romidepsin Antibiotics, Antineoplastic Antineoplastic Agents |