What side effects are associated with this type of intervention?

Treatments for Non-Hodgkin's Lymphoma, such as Parsaclisib (an enzyme inhibitor) and Polatuzumab-Vedotin (a targeted chemotherapy delivery agent), have specific side effects. Parsaclisib may cause gastrointestinal disturbances, fatigue, and liver enzyme abnormalities. Polatuzumab-Vedotin can lead to peripheral neuropathy, neutropenia, and infusion-related reactions. Both treatments may also result in general chemotherapy-related side effects like nausea, fatigue, and increased risk of infections.

What prior FDA approvals exist?

For the treatment of Non-Hodgkin's Lymphoma, the FDA has approved several drugs that are similar to Parsaclisib and Polatuzumab-Vedotin. Ibrutinib, an enzyme inhibitor targeting Bruton's tyrosine kinase, has been approved for various types of NHL. Additionally, Polatuzumab-Vedotin, which targets CD79b and delivers a cytotoxic agent directly to cancer cells, has been approved for use in combination with bendamustine and rituximab for relapsed or refractory diffuse large B-cell lymphoma. These approvals highlight the FDA's recognition of both enzyme inhibition and targeted chemotherapy delivery as effective strategies in the treatment of NHL.

What other types of research exist?

Promising novel alternatives for Non-Hodgkin's Lymphoma treatment include Bruton tyrosine kinase (BTK) inhibitors such as acalabrutinib and zanubrutinib, which have shown better tolerability and similar or superior efficacy compared to ibrutinib. Additionally, bispecific T cell engagers (BiTEs) like teclistamab and chimeric antigen receptor (CAR) T cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel are emerging as effective options. These therapies target specific molecules on cancer cells, offering a more personalized and potentially effective treatment approach.

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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)

Must not have

Uncontrolled intercurrent illness

Received or receiving any other agent which would be considered as a treatment for the lymphoma

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called parsaclisib, sometimes combined with polatuzumab-vedotin, along with standard cancer drugs in patients with high-risk diffuse large B-cell lymphoma. Parsaclisib blocks enzymes that help cancer grow, while polatuzumab-vedotin targets and kills cancer cells. The goal is to see if this combination works better than the standard treatment 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses.

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I am currently taking or have taken medication for my lymphoma.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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My cancer involves the brain or spinal cord.

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I am currently being treated for another cancer.

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I do not have any severe illnesses besides my current condition.

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Over 25% of my bone marrow has been radiated for another condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

44%

Nausea

41%

Cough

41%

Diarrhoea

41%

Vomiting

33%

Fatigue

33%

Constipation

26%

Neutropenia

26%

Dizziness

22%

Arthralgia

22%

Headache

22%

Abdominal pain

19%

Thrombocytopenia

19%

Hypotension

15%

Dyspnoea

15%

Hypokalaemia

15%

Hypophosphataemia

15%

Oedema peripheral

15%

Oropharyngeal pain

15%

Upper respiratory tract infection

15%

Chills

15%

Back pain

15%

Tachycardia

15%

Anaemia

15%

Decreased appetite

11%

Sinusitis

11%

Aspartate aminotransferase increased

11%

Dehydration

11%

Hyperglycaemia

11%

Myalgia

11%

Palpitations

11%

Pruritus

11%

Stomatitis

11%

Electrocardiogram QT prolonged

11%

Muscle spasms

11%

Muscular weakness

11%

Night sweats

11%

Peripheral swelling

11%

Candida infection

11%

Dry skin

11%

Pneumonia

Urinary tract infection

Alanine aminotransferase increased

Anxiety

Blister

Hypoalbuminaemia

Neck pain

Pain

Pain in extremity

Pyrexia

Rash

Rash papular

Wheezing

Bronchitis

Abdominal distension

Nasal congestion

Platelet count decreased

Asthenia

Blood alkaline phosphatase increased

Dysgeusia

Fall

Insomnia

Nasopharyngitis

Weight increased

Contusion

Dermatitis exfoliative

Acute kidney injury

Confusional state

Leukocytosis

Mental status changes

Pleural effusion

Renal tubular necrosis

Respiratory failure

Syncope

Urinary incontinence

Abdominal discomfort

Herpes zoster

Hypercalcaemia

Hypertension

Paraesthesia

Respiratory tract congestion

Rhinorrhoea

Seasonal allergy

Taste disorder

Tinnitus

Transaminases increased

Upper-airway cough syndrome

White blood cell count decreased

Anal incontinence

Hip fracture

Malignant pleural effusion

Haematuria

Neuropathy peripheral

Neutrophil count decreased

Pain in jaw

Weight decreased

Bacteraemia

Gastritis erosive

Depression

Drug hypersensitivity

Erythema

Hyperhidrosis

Vaginal discharge

100%

80%

60%

40%

20%

Study treatment Arm

Parsaclisib 30 mg QD

Parsaclisib 20 mg QD

Parsaclisib 45 mg QD

Parsaclisib 20 mg QD + R-ICE

Parsaclisib 20 mg + Itacitinib 300 mg

Parsaclisib 30 mg + Itacitinib 300 mg

Total

Parsaclisib 15 mg QD + R-ICE

Parsaclisib 5 mg QD

Parsaclisib 10 mg QD

Parsaclisib 15 mg QD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Parsaclisib

2017

Completed Phase 2

~680

Pegfilgrastim

2013

Completed Phase 3

~4440

Prednisone

2014

Completed Phase 4

~2500

Rituximab

1999

Completed Phase 4

~2990

Vincristine Sulfate

2005

Completed Phase 3

~10270

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include enzyme inhibitors and targeted chemotherapy delivery. Enzyme inhibitors, such as Parsaclisib, block specific enzymes that are essential for the growth and survival of lymphoma cells, effectively stopping their proliferation. Targeted chemotherapy delivery, like Polatuzumab-Vedotin, uses monoclonal antibodies to deliver cytotoxic drugs directly to cancer cells, thereby minimizing damage to healthy cells. This targeted approach not only enhances the efficacy of the treatment but also reduces systemic side effects, which is crucial for improving patient outcomes and quality of life.