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Parsaclisib + Standard Therapy for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Yucai Wang

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Myc expression >= 40% by immunohistochemistry (IHC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to death due to any cause, assessed up to 5 years

Awards & highlights

Study Summary

This trial is testing a new drug in combination with the standard drug therapy for high risk diffuse large B-cell lymphoma to see if it is more effective than the standard therapy alone.

Who is the study for?

This trial is for adults with newly diagnosed, high risk diffuse large B-cell lymphoma. Participants must have certain types of this cancer (non-GCB subtype or express specific proteins), be in specific stages, and have a good performance status. They need normal organ function tests and agree to use birth control if applicable. Excluded are pregnant individuals, those with uncontrolled illnesses, HIV on antiretroviral therapy, prior CNS lymphoma involvement, severe lung disease or heart failure.Check my eligibility

What is being tested?

The trial is testing the effectiveness of parsaclisib with or without polatuzumab vedotin plus standard R-CHOP therapy against R-CHOP alone. Parsaclisib inhibits enzymes for cell growth; polatuzumab delivers chemo directly to cancer cells; R-CHOP includes rituximab and various chemotherapy drugs aimed at stopping cancer spread.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as increased infection risk, liver enzyme changes indicating potential liver damage, blood disorders like anemia or clotting issues due to bone marrow suppression by chemotherapy drugs, fatigue from treatment burden on the body's resources.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer shows high levels of Myc protein.

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My cancer cells show high levels of Bcl-2 protein.

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My cancer has a MYC gene change detected by a special test.

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My cancer is at an advanced stage, but not the earliest or final stages.

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I am able to care for myself and perform daily activities.

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My kidneys are functioning well enough to clear waste.

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I have a new, untreated type of lymphoma that tests positive for CD20.

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My lymphoma is not of the germinal center B-cell type.

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I have been newly diagnosed with both aggressive and slow-growing lymphoma.

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My lymphoma is a high-grade type with specific genetic changes, but I can't undergo aggressive chemotherapy.

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My cancer cells highly express both Myc and Bcl-2 proteins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to death due to any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to death due to any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete metabolic response (CMR) rate (Dose Expansion)

Maximum tolerated dose (MTD) of parsaclisib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (Phase I)

Secondary outcome measures

Duration of response (Dose Expansion)

Duration of response (Pola Safety Lead-in)

Event-free survival (Dose Expansion)

+9 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

Active Control

Group I: Arm I (parsaclisib, R-CHOP)Experimental Treatment7 Interventions

Patients receive parsaclisib PO QD on days 1-10 or 1-14, rituximab IV or biosimilar substitute, cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV over 15 minutes on day 1. Patients also receive prednisone PO on days 1-5 and pegfilgrastim SC or biosimilar substitute on day 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (parsaclisib, R-CHOP, polatuzumab vedotin)Active Control8 Interventions

Patients receive parsaclisib PO once daily QD on days 1-10 or 1-14, polatuzumab vedotin IV over 90 minutes, rituximab IV or biosimilar substitute, cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV over 15 minutes on day 1. Patients also receive prednisone PO on days 1-5 and pegfilgrastim SC or biosimilar substitute on day 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Parsaclisib

2018

Completed Phase 2

~350

Pegfilgrastim

2013

Completed Phase 3

~4410

Prednisone

2014

Completed Phase 4

~2370

Rituximab

1999

Completed Phase 4

~1880

Vincristine Sulfate

2005

Completed Phase 3

~10110

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,734 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,103 Total Patients Enrolled

Yucai WangPrincipal InvestigatorMayo Clinic in Rochester

2 Previous Clinical Trials

145 Total Patients Enrolled

Media Library

Cyclophosphamide Clinical Trial Eligibility Overview. Trial Name: NCT04323956 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Arm I (parsaclisib, R-CHOP), Arm II (parsaclisib, R-CHOP, polatuzumab vedotin)

Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04323956 — Phase 1

Cyclophosphamide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04323956 — Phase 1

Frequently Asked Questions

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

What conditions does Parsaclisib typically address?

"Parsaclisib is conventionally used to mitigate pheochromocytomas but has also been proven effective in treating ulcerative colitis, varicella-zoster virus acute retinal necrosis and multiple myeloma."

Answered by AI

Has the FDA sanctioned Parsaclisib for medical use?

"Parsaclisib has only been tested in early stages, resulting in a score of 1 for safety. To date, there is limited evidence regarding the drug's efficacy and its impacts on human biology."

Answered by AI

What is the aim of this clinical endeavor?

"This trial will be conducted over a period of up to 21 days, with its primary outcome being the Complete Metabolic Response (CMR) rate. Secondary objectives include Progression-Free Survival, Incidence of Adverse Events in both Dose Expansion and Phase I stages, which are evaluated through CTCAE v 5.0 standard AE grading for Hematologic toxicity measures such as thrombocytopenia, neutropenia and leukopenia. Frequency distributions and other descriptive analysis techniques shall be used to analyse these outcomes."

Answered by AI

Is enrollment currently active for this experiment?

"The information on clinicaltrials.gov attests to the fact that this medical trial is presently enrolling patients. Initiated in mid-June 2020, its details were last refreshed at the start of June 2022."

Answered by AI

What other scientific investigations have utilized Parsaclisib?

"Parsaclisib was first researched in 1993 at the NIH Clinical Center located on Rockville Pike. Since then, 3001 studies have been completed while there are 1595 active trials; many of these being conducted out of Jacksonville, Florida."

Answered by AI

How many individuals are participating in the clinical trial?

"The trial necessitates 44 participants, meeting the specified criteria. Those interested can take part at one of two Mayo Clinic locations - Jacksonville, Florida or Scottsdale, Arizona."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Parsaclisib With or Without Polatuzumab Vedotin Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma

2020. "Parsaclisib With or Without Polatuzumab Vedotin Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04323956.

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