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Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)

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. Identifier: NCT03711578
Recruitment Status : Completed
First Posted : October 18, 2018
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Brief Summary:
To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL),

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: Tenalisib, Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Adult Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
Actual Study Start Date : November 25, 2018
Actual Primary Completion Date : June 16, 2020
Actual Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Tenalisib
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Drug: Tenalisib,
BID, Orally
Other Name: RP6530

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 7 months ]
    ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)

  2. Complete Response Rate [ Time Frame: 7 months ]
    CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.

  3. Progression Free Survival (PFS) [ Time Frame: From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months ]
    PFS is defined as the time of the first dose of Tenalisib to disease progression or death.

  4. Duration of Response (DoR) [ Time Frame: 7 months ]
    DoR is measured from the initial response to disease progression or death

Secondary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 8 months ]
    Safety and tolerability of Tenalisib

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. Patients with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:

    1. Follicular lymphoma (FL) G1, G2, or G3a
    2. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
    3. Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia (LPL/WM)
    4. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5 x10^9/L at the time of diagnosis and at study entry.
  2. Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received rituximab and alkylating agents.
  3. Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter ≥ 1.5 cm.
  4. Male or female patients > 18 years of age.
  5. ECOG performance status ≤ 2.
  6. Life expectancy of at least 3 months.
  7. Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:

    1. Hemoglobin ≥ 9 g/dl
    2. Absolute neutrophil count (ANC) ≥ 1 x 10^9/L
    3. Platelets ≥50 x 10^9/L (patient without BM involvement) and 30 x 10^9/L (patient with BM involvement)
    4. Total bilirubin ≤1.5 times the upper limit of normal (ULN)
    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if known liver involvement
    6. Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault method)
  8. Use of an effective means of contraception for female patients of child-bearing potential, and all male partners.
  9. Willingness and ability to comply with trial and follow-up procedures, give written informed consent.

Exclusion Criteria:

  1. FL grade 3b or transformed disease or CLL
  2. Cancer therapy within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D1. Corticosteroids (prednisone or equivalent) at a dose of < 20 mg daily are allowed. Corticosteroid should be stabilized for at least 1 week prior to C1D1
  3. Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
  4. History of having received an Allo-SCT
  5. Active hepatitis B or C infection
  6. Known history of human immunodeficiency virus (HIV) infection
  7. Evidence of ongoing severe systemic bacterial, fungal or viral infection
  8. Known primary central nervous system lymphoma or any preexisting neurologic manifestations
  9. Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension;
  10. Prior exposure to drug that specifically inhibits PI3K
  11. Pregnancy or lactation
  12. Myeloid growth factors or red blood cells/ platelet transfusion within 14 days prior to C1D1
  13. Drug administration within 1 week prior to C1D1

    1. Strong inhibitors or inducers of CYP3A4, CYP2C9, including grapefruit products, herbal supplements and drugs
    2. Substrates of CYP3A4 enzyme with a narrow therapeutic range

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): NCT03711578

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United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
Florida cancer specialists & Research Institute
Florida City, Florida, United States, 33401
Florida Cancer Specialist/ South
Fort Myers, Florida, United States, 33908
Florida Cancer Specialists/North
Saint Petersburg, Florida, United States, 33705
United States, Missouri
HCA Midwest Health Kansas City
Kansas City, Missouri, United States, 64132
United States, Tennessee
Tennessee Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Blacktown Hospital, Blacktown Cancer and Haematology Center
Blacktown, New South Wales, Australia, 2148
Australia, Queensland
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia,
Greenslopes,, Queensland, Australia, 4120
John Flynn Private Hospital,
Tugun, Queensland, Australia, 4224
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
  Study Documents (Full-Text)

Documents provided by Rhizen Pharmaceuticals SA:
Study Protocol  [PDF] December 4, 2018
Statistical Analysis Plan  [PDF] August 7, 2020

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Responsible Party: Rhizen Pharmaceuticals SA Identifier: NCT03711578    
Other Study ID Numbers: RP6530-1802
First Posted: October 18, 2018    Key Record Dates
Results First Posted: August 12, 2021
Last Update Posted: August 12, 2021
Last Verified: July 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:
Non-Hodgkin lymphoma,
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Phosphoinositide-3 Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action