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PI3K Inhibitor

Parsaclisib for Marginal Zone Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.

Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 161 weeks

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for people with a certain type of lymphoma who have not responded to other treatments.

Who is the study for?

This trial is for adults with Marginal Zone Lymphoma that has come back or hasn't responded to treatment. They can join if they have certain types of measurable cancer, are willing to provide a tissue sample, and haven't had specific prior treatments like PI3K inhibitors or recent stem cell transplants. People with large B-cell transformation, CNS lymphoma, active graft disease, or untreated hepatitis won't qualify.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of two ways to use Parsaclisib in patients with Marginal Zone Lymphoma who either haven’t tried a BTK inhibitor before or have used one previously. It aims to find out which regimen might work better for controlling this type of lymphoma.See study design

What are the potential side effects?

While not specified here, drugs like Parsaclisib often cause side effects such as diarrhea, nausea, fatigue, possible liver enzyme elevations indicating liver irritation, rash and other potential immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a lymph node or lymphoid cancer larger than 1.5 cm by 1.0 cm.

Select...

I am willing to have a biopsy or provide a recent biopsy sample.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My lymphoma is confirmed to be of the marginal zone type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 161 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 161 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 161 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) Based on Lugano Classification Criteria

Secondary outcome measures

Best Percent Change From Baseline in Target Lesion Size

Complete Response Rate (CRR) Based on Lugano Classification Criteria

Duration of Response (DOR)

+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 88 Patients • NCT02018861

63%

Fatigue

50%

Cough

38%

Upper respiratory tract infection

38%

Nausea

25%

Hypertension

25%

Hyperglycaemia

25%

Diarrhoea

25%

Tachycardia

25%

Oral herpes

13%

Alanine aminotransferase increased

13%

Headache

13%

Paraesthesia

13%

Herpes zoster

13%

Hepatic steatosis

13%

Acute kidney injury

13%

Anxiety

13%

Myalgia

13%

Bradycardia

13%

Hypokalaemia

13%

Neuropathy peripheral

13%

Hyperlipidaemia

13%

Pain

13%

Pyrexia

13%

Respiratory tract congestion

13%

Radiculopathy

13%

Neutropenia

13%

Night sweats

13%

Sinusitis

13%

Aspartate aminotransferase increased

13%

Hypophosphataemia

13%

Abdominal distension

13%

Haematuria

13%

Hypotension

13%

Lacrimation increased

13%

Nasal congestion

13%

Neutrophil count decreased

13%

Oedema peripheral

13%

Productive cough

13%

Vertigo

13%

Wound

13%

Abdominal pain

13%

Blood alkaline phosphatase increased

13%

Dyspepsia

13%

Dyspnoea

13%

Malaise

13%

Paranasal sinus discomfort

13%

Renal impairment

13%

Blood creatinine increased

13%

Blood phosphorus increased

13%

Spinal cord compression

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Parsaclisib 20 mg + Itacitinib 300 mg

Parsaclisib 30 mg + Itacitinib 300 mg

Total

Parsaclisib 20 mg QD + R-ICE

Parsaclisib 15 mg QD + R-ICE

Parsaclisib 5 mg QD

Parsaclisib 10 mg QD

Parsaclisib 15 mg QD

Parsaclisib 20 mg QD

Parsaclisib 30 mg QD

Parsaclisib 45 mg QD

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Participants who have not received a prior BTK inhibitor.

Group II: Cohort 1- Closed to Further enrollmentExperimental Treatment1 Intervention

Participants who have received prior ibrutinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parsaclisib

2018

Completed Phase 2

~350

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,055 Total Patients Enrolled

29 Trials studying Lymphoma

3,512 Patients Enrolled for Lymphoma

Claudia Corrado, MDStudy DirectorIncyte Corporation

2 Previous Clinical Trials

186 Total Patients Enrolled

2 Trials studying Lymphoma

186 Patients Enrolled for Lymphoma

Fred Zheng, MDStudy DirectorIncyte Corporation

5 Previous Clinical Trials

382 Total Patients Enrolled

2 Trials studying Lymphoma

171 Patients Enrolled for Lymphoma

Media Library

Parsaclisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03144674 — Phase 2

Lymphoma Research Study Groups: Cohort 1- Closed to Further enrollment, Cohort 2

Lymphoma Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT03144674 — Phase 2

Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03144674 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other medical studies have included Parsaclisib as a treatment?

"Parsaclisib was first researched in 2017 by scholars at Sapienza University. Currently, there are 10 completed studies and 17 ongoing trials involving parsaclisib. Many of these active clinical trials are based in Santa Maria, Arizona."

Answered by AI

What is the aim of this experiment?

"The investigators of this study aim to assess the Objective Response Rate (ORR) of participants over the course of 25 months. ORR is Based on Lugano Classification Criteria. Additionally, they will be looking at secondary outcomes like Duration of response and Best percentage change from baseline in target lesion size. Lastly, Progression-free survival will also be monitored."

Answered by AI

Could you please expand on the risks associated with Parsaclisib?

"Since there is only data supporting Parsaclisib's safety and no efficacy data, it received a score of 2."

Answered by AI

Is this clinical trial also taking place in other countries besides North America?

"This study is being conducted at 33 different medical facilities, some of which include Central Coast Medical Oncology in Santa Maria, UCLA Healthcare Hematology-Oncology in Santa Monica, and St. Joseph Heritage Healthcare in Santa Rosa."

Answered by AI

Are any places still available for people who want to join this clinical trial?

"The clinical trial noted on clinicaltrials.gov appears to be inactive, as the last update was over 4 months ago. This specific study is no longer recruiting patients, but there are 1,778 other trials with open recruitment at this time."

Answered by AI

Have other similar medical trials been conducted before?

"There are currently 17 live clinical trials for Parsaclisib across 115 cities and 26 countries. The first clinical trial for Parsaclisib was held in 2017. The study, sponsored by Incyte Corporation, involved 161 patients and completed its Phase 2 drug approval stage. Since 2017 years, 10 studies have been completed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

2017. "A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03144674.

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