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)

NCT03711578 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RP6530-1802
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

Non Hodgkin Lymphoma

Keywords

Non-Hodgkin lymphoma,; Tenalisib; RP6530

Outcome Measures

Primary Outcomes (4)

• Objective Response Rate (ORR)

  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)

  7 months

• Complete Response Rate

  CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.

  7 months

• Progression Free Survival (PFS)

  PFS is defined as the time of the first dose of Tenalisib to disease progression or death.

  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

• Duration of Response (DoR)

  DoR is measured from the initial response to disease progression or death

  7 months

Secondary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0

  8 months

Study Arms (1)

Tenalisib

EXPERIMENTAL

Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles

Drug: Tenalisib,

Interventions

Tenalisib, DRUG

BID, Orally

Also known as: RP6530

Tenalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:
• Follicular lymphoma (FL) G1, G2, or G3a
• Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
• Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia (LPL/WM)
• Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \<5 x10\^9/L at the time of diagnosis and at study entry.
• 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.
• Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter ≥ 1.5 cm.
• Male or female patients \> 18 years of age.
• ECOG performance status ≤ 2.
• Life expectancy of at least 3 months.
• Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
• Hemoglobin ≥ 9 g/dl
• Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L
• Platelets ≥50 x 10\^9/L (patient without BM involvement) and 30 x 10\^9/L (patient with BM involvement)
• Total bilirubin ≤1.5 times the upper limit of normal (ULN)

You may not qualify if:

• FL grade 3b or transformed disease or CLL
• 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
• Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
• History of having received an Allo-SCT
• Active hepatitis B or C infection
• Known history of human immunodeficiency virus (HIV) infection
• Evidence of ongoing severe systemic bacterial, fungal or viral infection
• Known primary central nervous system lymphoma or any preexisting neurologic manifestations
• 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;
• Prior exposure to drug that specifically inhibits PI3K
• Pregnancy or lactation
• Myeloid growth factors or red blood cells/ platelet transfusion within 14 days prior to C1D1
• Drug administration within 1 week prior to C1D1
• Strong inhibitors or inducers of CYP3A4, CYP2C9, including grapefruit products, herbal supplements and drugs
• Substrates of CYP3A4 enzyme with a narrow therapeutic range

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (12)

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Florida cancer specialists & Research Institute

Florida City, Florida, 33401, United States

Location

Florida Cancer Specialist/ South

Fort Myers, Florida, 33908, United States

Location

Florida Cancer Specialists/North

St. Petersburg, Florida, 33705, United States

Location

HCA Midwest Health Kansas City

Kansas City, Missouri, 64132, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Blacktown Hospital, Blacktown Cancer and Haematology Center

Blacktown, New South Wales, 2148, Australia

Location

Brisbane Clinic for Lymphoma, Myeloma and Leukaemia,

Greenslopes, Queensland, 4120, Australia

Location

John Flynn Private Hospital,

Tugun, Queensland, 4224, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

tenalisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Prajak Barde MD
• Organization: Rhizen Pharmaceuticals

pjb@rhizen.com

+41325800175

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: November 25, 2018
• Primary Completion: June 16, 2020
• Study Completion: October 16, 2020
• Last Updated: August 12, 2021
• Results First Posted: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); AU (4)