Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits

parsaclisib

Incyte Medical Monitor

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

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

ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphoma, as determined by an Independent Review Committee (IRC). CR: target nodes/nodal masses regressed to ≤1.5 centimeters (cm) in the longest transverse diameter (LDi); no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate. PR: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites; absent/regressed nonmeasured lesions (but no increase); spleen regressed by \>50% in length beyond normal; and no new lesions.

CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphoma, as determined by an IRC. CR was defined as: target nodes/nodal masses regressed to ≤1.5 cm in the LDi; no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate.

DOR was defined as the time from the first documented evidence of CR or PR until disease progression or death from any cause among participants who achieved an objective response, as determined by radiographic disease assessment provided by an IRC. Progressive disease was defined as ≥1 of the following: abnormal individual node/lesion meeting specific criteria; new/recurrent splenomegaly; new/clear progression of pre-existing nonmeasured lesions; regrowth of any previously resolved lesions; new node \>1.5 cm in any axis; new extranodal site \>1.0 cm in any axis; assessable disease of any size attributable to lymphoma; new/recurrent involvement of bone marrow.

PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. Progressive disease was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Overall survival was defined as the time from the date of the first dose of study treatment until death from any cause.

Target lesion size was measured by the sum of the products of the diameters of all target lesion sizes. The best percent change from Baseline was defined as the largest decrease, or smallest increase if no decrease, from Baseline in target lesion sizes on/before new anti-lymphoma therapy during the study. Percentage change was calculated as (\[the post-Baseline value minus the Baseline value\] / the Baseline value) x 100.

An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug.

An adverse event was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

Incyte Biosciences Japan GK

Treatment-emergent adverse events (TEAE ), defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported.

Participants received parsaclisib 20 milligrams (mg) once daily for 8 weeks, followed by 2.5 mg once daily, continuously. Participants received treatment until disease progression, death, hematopoietic stem cell transplantation (HSCT) (if eligible), unacceptable toxicity, or consent withdrawal

Parsaclisib 20 mg/2.5 mg

Total

Participants received parsaclisib 20 milligrams (mg) once daily for 8 weeks, followed by 2.5 mg once daily, continuously. Participants received treatment until disease progression, death, hematopoietic stem cell transplantation (HSCT) (if eligible), unacceptable toxicity, or consent withdrawal.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Independent Review Committee

Investigator

Target lesion size was measured by the sum of the products of the diameters of all target lesion sizes.

Only participants with available data (who had measurable regions) were analyzed.

Target lesion size, as determined by Independent Review Committee and the Investigator

Study Director

Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. Confidence intervals were calculated based on the exact method for binomial distributions.

Objective Response Rate (ORR)

Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.

Complete Response Rate (CRR)

Full Analysis Set. Only participants with a CR or PR were analyzed. The 95% confidence interval was calculated using the generalization of Brookmeyer and Crowley's method with log-log transformation.

Duration of Response (DOR)

Fully Analysis Set. The 95% confidence interval was calculated using the generalization of Brookmeyer and Crowley's method with log-log transformation.

Progression-free Survival (PFS)

Full Analysis Set. The 95% confidence interval was calculated using the generalization of Brookmeyer and Crowley's method with log-log transformation.

Overall Survival

Full Analysis Set. Only participants with available data (who had measurable regions) were analyzed.

Best Percentage Change in Target Lesion Size From Baseline, as Determined by Independent Review Committee and the Investigator

Safety Population: all enrolled participants who received at least 1 dose of parsaclisib

Spots Global Cancer Trial Database for Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

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Conditions

Interventions

Study Description

Keywords

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Contact Details

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