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Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

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 : Completed
First Posted : December 10, 2018
Last Update Posted : September 28, 2021
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

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.

Condition or disease Intervention/treatment Phase
T Cell Lymphoma Drug: Tenalisib Drug: Romidepsin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 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
Actual Primary Completion Date : May 14, 2021
Actual Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: Tenalisib+Romidepsin
Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
Drug: Tenalisib
Tenalisib, BID orally daily
Other Name: RP6530

Drug: Romidepsin
Romidepsin IV

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Overall response rate (ORR) with Tenalisib and Romidepsin combination [ Time Frame: 12 weeks ]
    No. of patients with partial and complete response

  2. 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

  3. Maximum observed plasma concentration (Cmax) [ Time Frame: 8 days ]
    Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination

Information from the National Library of Medicine

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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:

  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.

    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:

  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:

    • 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.

Information from the National Library of Medicine

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

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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
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
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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: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhizen Pharmaceuticals SA:
T cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibiotics, Antineoplastic
Antineoplastic Agents
Phosphoinositide-3 Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action