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PI3K Inhibitor

Parsaclisib for Follicular Lymphoma (CITADEL-203 Trial)

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

Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a

Ineligible for hematopoietic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 148 weeks

Awards & highlights

CITADEL-203 Trial Summary

This trial will test if a new drug, parsaclisib, is effective in treating people with a certain type of blood cancer that has come back or does not respond to treatment.

Who is the study for?

This trial is for adults with a type of blood cancer called follicular lymphoma that has come back or hasn't responded to treatment. They should be fairly active and able, have measurable cancer signs on scans, and must have tried at least two other treatments but can't get a stem cell transplant. People with certain viral infections, brain involvement by their lymphoma, or previous specific cancer treatments are not eligible.Check my eligibility

What is being tested?

The study is testing the effectiveness of a drug named Parsaclisib in patients who have relapsed (cancer has returned) or refractory (not responding to treatment) follicular lymphoma. The main goal is to see how well the tumor responds to this medication.See study design

What are the potential side effects?

Possible side effects of Parsaclisib may include digestive issues like nausea and diarrhea, liver enzyme changes which could indicate liver injury, fatigue, coughing, fever, and potential risks for infection due to immune system effects.

CITADEL-203 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My lymphoma is a type called follicular and it has come back or didn’t respond to treatment.

Select...

I cannot undergo a stem cell transplant.

Select...

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

Select...

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

Select...

I have undergone at least 2 different systemic treatments.

Select...

I am 18 years old or older.

CITADEL-203 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 148 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 148 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 148 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 With Parsaclisib Based on Lugano Classification Response Criteria

Secondary outcome measures

Best Percent Change From Baseline in Target Lesion Size

Complete Response Rate With Parsaclisib Based on Lugano Classification Response 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

CITADEL-203 Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QDExperimental Treatment1 Intervention

Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

Group II: Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QWExperimental Treatment1 Intervention

Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parsaclisib

2018

Completed Phase 2

~350

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,039 Total Patients Enrolled

29 Trials studying Lymphoma

3,496 Patients Enrolled for Lymphoma

Claudia Corrado, MDStudy DirectorIncyte Corporation

2 Previous Clinical Trials

170 Total Patients Enrolled

2 Trials studying Lymphoma

170 Patients Enrolled for Lymphoma

Fred Zheng, MD, PhDStudy DirectorIncyte Corporation

1 Previous Clinical Trials

137 Total Patients Enrolled

Media Library

Parsaclisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03126019 — Phase 2

Lymphoma Research Study Groups: Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW, Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD

Lymphoma Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT03126019 — Phase 2

Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03126019 — Phase 2

Frequently Asked Questions

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

What goals are researchers hoping to achieve through this trial?

"The main objective of this trial, to be assessed at Week 8, 16 and 24 then every 12 weeks until Week 96 and every 24 Weeks thereafter (up to approximately one year), is the Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria. Secondary outcomes include Progression-free Survival with parsaclisib defined as time from first dose until earliest date of disease progression or death; Complete response rate with parsaclisib based on Lugano classification criteria; Duration of response measured by time from documented evidence of CR/PR till disease progression or death among those achieving an objective response."

Answered by AI

What is the maximum participant limit for this research?

"Currently, the trial is not accepting new participants. This research was initially posted on March 14th 2018 and saw its last update on October 4th 2022. If you're in search of other studies, there are 1,719 clinical trials recruiting people with lymphoma and 17 admitting patients who will receive Parsaclisib as a treatment option."

Answered by AI

Can you provide a list of the locales in which this trial is being conducted?

"This particular clinical trial is currently being conducted in 25 different cities, including Kansas City, Durham and Charleston. To be as efficient as possible with travel demands, it may beneficial to select the site located closest to you if you choose to join."

Answered by AI

Has a trial of this kind ever been conducted before?

"To date, 17 Parsaclisib clinical trials have been performed across 115 cities and 26 countries. The original study of 161 participants was sponsored by Incyte Corporation in 2017, which has since been followed up with 10 drug approval stages as part of Phase 2."

Answered by AI

Is enrollment for this medical trial ongoing?

"The particulars of the clinical trial suggest it is not presently looking for enrollees. It was posted on 3/14/2018 and last updated on 10/14/2022, but 1736 other studies are actively seeking participants right now."

Answered by AI

What other exploratory experiments have made use of Parsaclisib?

"In 2017, the first trials for parsaclisib were conducted at Yakima Valley Memorial Hospital/North Star. Since then, 10 clinical studies have been concluded and 17 are presently underway; many of these in Kansas City Missouri."

Answered by AI

Has Parsaclisib been given the go-ahead by regulatory bodies?

"Despite being in its second phase of clinical trials, there is sufficient data to confidently assess Parsaclisib's safety as a 2 on our scale. There have been no studies yet conducted that evaluate the efficacy of this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

2018. "A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03126019.

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