Parsaclisib Combinations for B-Cell Cancers
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ibrutinib
- Itacitinib
- Parsaclisib
- Ruxolitinib
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School