Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

INCB053914 in combination with INCB050465.

Dose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria.

Dose Expansion: Recommended dose from the dose-escalation study.

INCB053914

Dose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria.

Dose Expansion: Recommended dose from the dose-escalation study.

INCB050465

Fred Zheng, MD

The purpose of this study is to evaluate the safety and tolerability of INCB053914 in combination with INCB050465 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma

A Phase 1b, Multicenter, Open-Label Study of the Safety and Tolerability of INCB053914 in Combination With INCB050465 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

Minimum observed plasma concentration during the dosing interval.

Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.

Defined as the percentage of participants with a complete remission (CR)/complete metabolic response (CMR) or partial remission (PR)/partial metabolic response (PMR) as defined by investigator assessment per revised Lugano classification criteria for lymphomas.

Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression or death from any cause among participants who achieve an objective response, as determined by radiographic disease assessment.

Defined as the time from the date of the first dose of any study drug until the earliest date of disease progression, as determined by radiographic disease assessment, or death from any cause, whichever occurs first.

Incyte Corporation

Lymphoma, Mantle-Cell

Mantle Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.

Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.

parsaclisib will be administered orally once daily.

parsaclisib

rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.

rituximab

bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.

bendamustine

placebo will be administered orally once daily

Placebo

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.

A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell Lymphoma

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.

Defined as the time from the date of randomization until death from any cause.

Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.

Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.

Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.

Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC.

Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC.

Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first.

Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment.

Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first.

Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug/treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma	NCT03688152	Relapsed Diffus... Refractory Diff...	INCB053914 INCB050465	18 Years -	Incyte Corporation
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma	NCT04849715	Mantle Cell Lym...	parsaclisib rituximab bendamustine Placebo	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for pi3kδ

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Spots Global Cancer Trial Database for pi3kδ

Every month we try and update this database with for pi3kδ cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pi3kδ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.