112 Participants Needed

Parsaclisib Combinations for B-Cell Cancers

Recruiting at 131 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Incyte Corporation
Must be taking: Parsaclisib, Itacitinib, Ruxolitinib, Ibrutinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves continuing treatment with specific drugs, you may need to discuss your current medications with the study team.

Is ibrutinib safe for use in humans?

Ibrutinib has been shown to have an acceptable safety profile in clinical studies for B-cell cancers, with less than 10% of patients discontinuing due to side effects. It is generally well-tolerated, although some patients may experience adverse events.12345

What makes the drug combination of Parsaclisib, Ibrutinib, Itacitinib, and Ruxolitinib unique for B-cell cancers?

This drug combination is unique because it includes Ibrutinib, a first-in-class inhibitor that targets Bruton's tyrosine kinase (BTK), which is crucial for B-cell survival and proliferation. Combining Ibrutinib with other agents like Parsaclisib, Itacitinib, and Ruxolitinib may enhance its effectiveness by targeting multiple pathways involved in B-cell cancer growth, potentially offering a more comprehensive treatment approach.678910

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow the study's schedule and treatment plans.
You are willing to prevent pregnancy or becoming a father during the study.
My condition is stable as confirmed by my doctor.
See 5 more

Exclusion Criteria

Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol
I can get parsaclisib alone or with other specific treatments outside a study.
Pregnant or breastfeeding women
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue treatment with parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib, maintaining the same dose and schedule as in the parent Protocol

Through study completion, an average of 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ibrutinib
  • Itacitinib
  • Parsaclisib
  • Ruxolitinib
Trial OverviewThe 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.
Participant Groups
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.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
  • Graft-versus-host disease
🇺🇸
Approved in United States as Imbruvica for:
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
  • Graft-versus-host disease
🇨🇦
Approved in Canada as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
🇯🇵
Approved in Japan as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

In a phase 1b study involving patients with relapsed/refractory chronic lymphocytic leukemia, the combination of ibrutinib with bendamustine and rituximab (BR) showed a high overall response rate of 93.3%, with significant improvements in complete responses over time.
The study demonstrated that ibrutinib can enhance the efficacy of chemoimmunotherapy without adding prolonged hematologic toxicity, suggesting a promising treatment strategy for patients with this type of leukemia.
The Bruton tyrosine kinase inhibitor ibrutinib with chemoimmunotherapy in patients with chronic lymphocytic leukemia.Brown, JR., Barrientos, JC., Barr, PM., et al.[2021]
Ibrutinib is a first-in-class oral Bruton's tyrosine kinase inhibitor that effectively blocks B-cell signaling, leading to reduced proliferation and increased cell death in B cell malignancies, including chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL).
It has received FDA approval for treating MCL in previously treated patients based on phase Ib/II study results and is currently undergoing further phase III trials for CLL, diffuse large B cell lymphoma (DLBCL), and other B cell cancers.
Ibrutinib: first global approval.Cameron, F., Sanford, M.[2022]
The combination of ibrutinib and nivolumab demonstrated an acceptable safety profile in 141 patients with relapsed or refractory B-cell malignancies, with only one dose-limiting toxicity reported, indicating that this treatment approach is generally safe for patients.
Preliminary results showed promising efficacy, with overall response rates of 61% in high-risk chronic lymphocytic leukaemia, 33% in follicular lymphoma, and 36% in diffuse large B-cell lymphoma, suggesting that this combination therapy could be effective for these conditions.
Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study.Younes, A., Brody, J., Carpio, C., et al.[2021]

References

The Bruton tyrosine kinase inhibitor ibrutinib with chemoimmunotherapy in patients with chronic lymphocytic leukemia. [2021]
Ibrutinib: first global approval. [2022]
Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study. [2021]
A Phase 1b/2 Study of the Bruton Tyrosine Kinase Inhibitor Ibrutinib and the PD-L1 Inhibitor Durvalumab in Patients with Pretreated Solid Tumors. [2021]
[Ibrutinib: A new drug of B-cell malignancies]. [2021]
Ibrutinib: a review of its use in patients with mantle cell lymphoma or chronic lymphocytic leukaemia. [2022]
Pharmaceutical approval update. [2021]
Identification of potential ibrutinib combinations in hematological malignancies using a combination high-throughput screen. [2021]
Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. [2021]
Ibrutinib: a first in class covalent inhibitor of Bruton's tyrosine kinase. [2021]