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PI3K Inhibitor

Parsaclisib for Mantle Cell Lymphoma ((CITADEL-205) 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

Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy

Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 165 weeks

Awards & highlights

(CITADEL-205) Trial Summary

This trial is testing a new cancer drug for people with mantle cell lymphoma who haven't responded to other treatments. It will evaluate how well the drug works and how safe it is.

Who is the study for?

This trial is for adults over 18 with mantle cell lymphoma that hasn't responded well to previous treatments. They must have measurable cancer signs and be in a stable enough condition to perform daily activities (ECOG ≤ 2). People can't join if they've had certain brain lymphomas, recent stem cell transplants, active immune reactions from transplants, or specific liver diseases.Check my eligibility

What is being tested?

The study tests two different ways of giving the drug Parsaclisib to people with mantle cell lymphoma who have tried other treatments before. It's an open-label Phase 2 trial, meaning everyone knows what treatment they're getting and there are two participant groups based on their prior treatments.See study design

What are the potential side effects?

Parsaclisib may cause side effects like diarrhea, nausea, fatigue, coughing, fever, rash or infections. Since it targets specific cells in the immune system involved in cancer growth but also normal defense mechanisms against germs.

(CITADEL-205) Trial Eligibility Criteria

Inclusion Criteria

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

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My cancer can be seen on scans.

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My last cancer treatment did not work or my cancer got worse after it.

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

(CITADEL-205) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 165 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 165 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 165 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)

Secondary outcome measures

Best Percent Change From Baseline in Target Lesion Size

Complete Response Rate (CRR)

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-205) Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)Experimental Treatment1 Intervention

Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.

Group II: Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)Experimental Treatment1 Intervention

Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.

Group III: Cohort 1: Treatment B (Exposed to Ibrutinib)Experimental Treatment1 Intervention

Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

Group IV: Cohort 1: Treatment A (Exposed to Ibrutinib)Experimental Treatment1 Intervention

Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parsaclisib

2018

Completed Phase 2

~350

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,003 Total Patients Enrolled

29 Trials studying Lymphoma

3,460 Patients Enrolled for Lymphoma

Fred Zheng, MDStudy DirectorIncyte Corporation

5 Previous Clinical Trials

330 Total Patients Enrolled

2 Trials studying Lymphoma

119 Patients Enrolled for Lymphoma

Media Library

Parsaclisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03235544 — Phase 2

Lymphoma Research Study Groups: Cohort 1: Treatment A (Exposed to Ibrutinib), Cohort 1: Treatment B (Exposed to Ibrutinib), Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve), Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

Lymphoma Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT03235544 — Phase 2

Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03235544 — Phase 2

Frequently Asked Questions

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

What objectives is this experiment attempting to fulfill?

"The primary aim of this 165 week-long trial is to assess the Objective Response Rate. Additionally, researchers are also looking into Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) which refers to medical occurrences that may be linked with a drug but do not necessarily require hospitalization or lead to death, Progression-free survival defined as time between first dose and disease progression/death from any cause, and PFS meaning time between first dose until earliest date of disease progression as determined by radiographic assessment."

Answered by AI

Is it still possible for eligible individuals to join this clinical experiment?

"At this juncture, this trial is not enrolling new patients. Although first posted on November 20th 2017 and last updated on July 7th 2022, other trials may be of interest to you; 1720 studies are recruiting patients with lymphoma and there are seventeen clinical trials looking for participants taking Parsaclisib."

Answered by AI

How many medical centers are offering this trial to participants?

"Currently, 21 centres are offering enrollment for this trial. The nearest sites to Maywood, Hattiesburg and Niles can be found from the list of available locations; selecting a local site is strongly encouraged to reduce travel demands."

Answered by AI

Has the regulatory agency sanctioned Parsaclisib for medical use?

"Parsaclisib has been given a rating of 2, as this Phase 2 trial has not yet showcased its efficacy but does provide supporting evidence for safety."

Answered by AI

How many participants are currently enrolled in this medical trial?

"Unfortunately, recruitment for this particular trial has closed. The initial posting was on November 20th 2017 and the study's last update was July 7th 2022. If you are considering other studies, there are currently 1720 trials actively recruiting participants with lymphoma and a further 17 searching for those taking Parsaclisib."

Answered by AI

Is this a pioneering research endeavor?

"Presently, there are 17 Parsaclisib clinical trials underway in 115 cities across 26 nations. The first of such studies was launched by Incyte Corporation in 2017 and included 161 patients through its Phase 2 drug approval phase. To date, 10 experiments have been finalized since the initiation of this endeavor three years ago."

Answered by AI

Have any other research studies been conducted utilizing Parsaclisib?

"Presently, 17 clinical trials are researching the efficacy of Parsaclisib. Of those, 3 are currently in Phase III development. Most Parsaclisib studies originate from Knoxville, Tennessee; however there is a network of 953 sites running related research worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

2017. "A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03235544.

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