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.

← Back to Search

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 is for people who have already been taking parsaclisib in other studies, and will continue to take it either alone or with other drugs.

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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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

Side effects data

From 2021 Phase 1 & 2 trial • 88 Patients • NCT02018861

100%

Night sweats

100%

Constipation

100%

Stomatitis

100%

Neutropenia

100%

Taste disorder

100%

White blood cell count decreased

100%

Anaemia

100%

Thrombocytopenia

100%

Pain in extremity

100%

Encephalopathy

100%

Device related infection

100%

Dizziness

100%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Parsaclisib 20 mg QD + R-ICE

Parsaclisib 15 mg QD + R-ICE

Parsaclisib 30 mg + Itacitinib 300 mg

Parsaclisib 20 mg + Itacitinib 300 mg

Total

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

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

2018

Completed Phase 2

~440

Do I qualify?Apply below to find out

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.