Continued Treatment Study for Patients with B-Cell Cancers Previously in Parsaclisib Trials

Sponsor: Incyte Corporation

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04509700

Provider View

This study allows patients with B-cell cancers who were part of previous trials to continue receiving the drug parsaclisib, either alone or with other medications, if they are benefiting from it and cannot get it outside of a clinical trial.

Patient Parameters

Program Overview

This Phase 2 study is designed to continue providing the drug parsaclisib to patients with B-cell cancers who were part of earlier trials. Patients can receive parsaclisib alone or with other drugs like itacitinib, ruxolitinib, or ibrutinib, as long as they are benefiting from the treatment and cannot access it outside of a clinical trial. The study will monitor the safety of the treatment and any side effects.

Description

The main goal of this study is to allow patients who are already benefiting from parsaclisib treatment in previous trials to continue receiving it. Patients can take parsaclisib by itself or with other drugs such as itacitinib, ruxolitinib, or ibrutinib. To be eligible, patients must be currently enrolled in a trial sponsored by Incyte, be benefiting from the treatment, and not have access to the drug outside of a clinical trial. The study will keep the same dosage and schedule as the previous trial and will collect information on any side effects.

Eligibility Criteria

Inclusion Criteria

  • Currently part of an Incyte-sponsored trial using parsaclisib.
  • Tolerating the treatment well in the current trial.
  • Benefiting from the treatment, as judged by the doctor.
  • Disease is stable or better, according to the doctor.
  • Following the rules of the current trial.
  • Willing to attend scheduled visits and follow the treatment plan, including taking preventive medication for certain infections.
  • Agree to avoid pregnancy or fathering children.
  • Able to understand and willing to sign a consent form.

Exclusion Criteria

  • Stopped treatment in the current trial for any reason.
  • Can get parsaclisib or the combination treatment outside of a clinical trial.
  • Have an uncontrolled illness or condition that could make the study unsafe or difficult to follow.
  • Pregnant or breastfeeding.

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