Loading clinical trials...

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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

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)

NCT03711578•Rhizen Pharmaceuticals SA

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

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
+5 more criteria

Locations (12)

Clearview Cancer Institute

Huntsville, Alabama, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Florida cancer specialists & Research Institute

Florida City, Florida, United States

Florida Cancer Specialist/ South

Fort Myers, Florida, United States

Florida Cancer Specialists/North

St. Petersburg, Florida, United States

HCA Midwest Health Kansas City

Kansas City, Missouri, United States

Tennessee Oncology

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Blacktown Hospital, Blacktown Cancer and Haematology Center

Blacktown, New South Wales, Australia

Brisbane Clinic for Lymphoma, Myeloma and Leukaemia,

Greenslopes, Queensland, Australia

Key Dates

Start Date

November 25, 2018

Primary Completion Date

June 16, 2020

Completion Date

October 16, 2020

Last Updated

August 12, 2021

Enrollment

ACTUAL participants

Conditions

Non Hodgkin Lymphoma

Interventions

Tenalisib,

DRUG

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

View study

RECRUITINGPHASE1/PHASE2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

NCT05442515

B-NHLB-Non Hodgkin Lymphoma+9 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Familial Investigations of Childhood Cancer Predisposition

Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

Improving Communication and Building a Stronger Medical Home Among Spanish-speaking Families

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors