Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Tenalisib

Phosphoinositide-3 Kinase Inhibitors

Enzyme Inhibitors

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

Tenalisib,

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

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)

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)

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

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

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

Rhizen Pharmaceuticals SA

Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.

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

Tenalisib,: BID, Orally

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Australia

Region of Enrollment

Prajak Barde MD

Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment

Objective Response Rate (ORR)

Complete Response Rate

Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment

Progression Free Survival (PFS)

Duration of Response (DoR)

Patients who received at least 1 dose of study medication

Spots Global Cancer Trial Database for 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)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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