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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03770000
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : August 17, 2020
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)
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 : August 2020
Estimated Study Completion Date : November 2020

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 identifier (NCT number): NCT03770000

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Contact: Swaminathan P Iyer, MD +001 713 745 1113
Contact: Prajak Barde, MD +41 32 580 0175

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United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Ann Mohrbacher, MD         
University of California, Hellen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94143
Contact: Ai Z Weiyun, MD, PhD         
Contact: Jessica Avila   
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Bradley Haverkos, MD         
United States, Florida
University of Miami-Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Juan Pablo Alderuccio, MD         
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mary Jo Lechowicz, MD         
Contact: David J Reagan   
United States, Illinois
Rush University Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Timothy M Kuzel, MD, FACP         
Contact: Jessica L Chorak   
United States, Kansas
The University of Kansas Cancer Center Recruiting
Fairway, Kansas, United States, 66205
Contact: Anusha Vallurupalli, MD         
United States, Kentucky
Norton Cancer Institute, St Matthews Campus Recruiting
Louisville, Kentucky, United States, 40207
Contact: Don Ambrose Stevens, MD         
Contact: Krentz, G Erin   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ryan Wilcox, MD   
United States, New Jersey
John Theurer Cancer Center, Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Tatyana Feldman Tatyana Feldman, MD         
Contact: Azzollini, Kelly   
United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: Suchitra Sundaram, MD         
United States, Ohio
Cleveland Clinic Taussig Cancer Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Deepa Jagadeesh, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Craig Okada, MD         
United States, Tennessee
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-5505
Contact: Nishitha Reddy, MD         
Contact: Dudley, V Channing   
United States, Texas
The University of Texas MD Anderson Cancer Center, Recruiting
Houston, Texas, United States, 77030
Contact: Swaminathan P Iyer, MD         
The University of Texas MD Anderson Cancer Center, Recruiting
Houston, Texas, United States, 77030
Contact: Auris Huen, MD         
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
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Responsible Party: Rhizen Pharmaceuticals SA Identifier: NCT03770000    
Other Study ID Numbers: RP6530+Romidepsin-1805
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
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
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibiotics, Antineoplastic
Antineoplastic Agents