What side effects are associated with this type of intervention?

Common treatments for B-Cell cancers, such as PI3K inhibitors like Parsaclisib, often have side effects including gastrointestinal issues (diarrhea, nausea), liver enzyme abnormalities, and hematologic toxicities (neutropenia, thrombocytopenia). Other frequent adverse events can include fatigue, rash, and infections. These side effects are consistent with those observed in clinical trials for similar agents targeting the PI3K pathway.

What prior FDA approvals exist?

The FDA has approved several treatments for B-Cell cancers that are similar to Parsaclisib, a selective PI3Kδ inhibitor. Idelalisib, another PI3Kδ inhibitor, is approved for relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab, as well as for relapsed follicular B-cell non-Hodgkin lymphoma and small lymphocytic lymphoma. Duvelisib, a dual PI3K-δ,γ inhibitor, is approved for the treatment of relapsed or refractory CLL and small lymphocytic lymphoma after at least two prior therapies. These approvals highlight the therapeutic potential of targeting the PI3K pathway in B-Cell malignancies.

What other types of research exist?

Promising novel alternatives to Parsaclisib for B-Cell cancers in 2024 include: 1) Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, which has shown efficacy in various B-Cell malignancies. 2) Acalabrutinib, another BTK inhibitor, offering a favorable safety profile. 3) Venetoclax, a BCL-2 inhibitor, effective in chronic lymphocytic leukemia (CLL) and other B-Cell cancers. 4) Zanubrutinib, a next-generation BTK inhibitor, providing targeted therapy with potentially fewer side effects. These alternatives have demonstrated promising results in clinical trials and are viable options for patients.

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BTK Inhibitor

Parsaclisib Combinations for B-Cell Cancers

Phase 2

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 years

Awards & highlights

Summary

This trial continues to provide the drug parsaclisib, alone or with other drugs, to patients who are already benefiting from it in previous studies. These patients cannot get the drug outside of this research. Parsaclisib helps control cancer by blocking proteins that cancer cells need to grow.

Who is the study for?

This trial is for people already in Incyte-sponsored parsaclisib studies who are tolerating treatment well, have stable B-cell malignancies, and follow study rules. They must be benefiting from current treatments with parsaclisib alone or combined with itacitinib, ruxolitinib, or ibrutinib and not pregnant nor breastfeeding.

What is being tested?

The Phase 2 trial provides ongoing access to the drug parsaclisib as a single agent or paired with itacitinib, ruxolitinib, or ibrutinib for participants previously enrolled in related trials. It's an open-label study meaning everyone knows what treatment they're getting.

What are the potential side effects?

Possible side effects of parsaclisib include infections due to lowered immunity (participants will take drugs to prevent this), digestive issues, fatigue, liver problems. Side effects may vary when combined with other drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 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

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

Dermatitis exfoliative

Contusion

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: parsaclisib + ruxolitinibExperimental Treatment1 Intervention

Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.

Group II: parsaclisib + ibrutinibExperimental Treatment1 Intervention

Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.

Group III: parsaclisibExperimental Treatment1 Intervention

Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.

Group IV: parsaclicib + itacitinibExperimental Treatment1 Intervention

Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parsaclisib

2017

Completed Phase 2

~680

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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 B-Cell Cancers often involve targeted therapies that inhibit specific molecular pathways crucial for cancer cell survival and proliferation. Parsaclisib, a selective PI3Kδ inhibitor, works by blocking the phosphoinositide 3-kinase delta (PI3Kδ) pathway, which is essential for the growth and survival of B-Cell malignancies. By inhibiting this pathway, Parsaclisib can reduce cancer cell proliferation and induce apoptosis (cell death). This mechanism is particularly important for B-Cell Cancer patients because it offers a more targeted approach, potentially leading to fewer side effects compared to traditional chemotherapy. Other similar treatments include inhibitors targeting the B-cell receptor (BCR) signaling pathway and the mammalian target of rapamycin (mTOR) pathway, both of which are also critical for B-Cell Cancer cell survival.

Targeting oncogenic and epigenetic survival pathways in lymphoma.