Expanded Access Program for Pirtobrutinib for Patients with B-Cell Cancer

Sponsor: Loxo Oncology, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05172700

Provider View

This program provides access to the drug pirtobrutinib for patients with B-cell cancer who have already received treatment and are not eligible for current clinical trials.

Patient Parameters

Program Overview

This program is designed to offer the drug pirtobrutinib to patients with B-cell cancer who have already been treated but cannot join an ongoing clinical trial for this medication. If a doctor believes a patient qualifies for this program, they can contact the drug company, Lilly, to discuss participation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with one of the following B-cell cancers:
    • Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and have already tried five types of treatments, including chemotherapy and specific targeted therapies.
    • Mantle Cell Lymphoma (MCL) that has been treated before with a specific type of targeted therapy.
    • Richter's Transformation (RT) that has been treated with specific therapies.
    • Waldenstrom Macroglobulinemia (WM) that has been treated with chemotherapy and targeted therapies.
  • Not eligible for any current pirtobrutinib clinical trials.

Exclusion Criteria

  • Poor organ function.
  • Serious heart disease.
  • Recent stem cell transplant or CAR-T cell therapy within the last 60 days.
  • Positive test for HIV or active hepatitis B, C, or CMV infections.
  • Uncontrolled autoimmune blood disorders.
  • Significant digestive absorption issues.
  • Need for blood thinners like warfarin or similar medications.

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Receive detailed information about this treatment opportunity to review with your healthcare provider.