RECRUITING

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.

Official Title

A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia

Quick Facts

Study Start:2025-07-30
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process
  2. * Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy
  3. * Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
  4. * Have a platelet count less than 30,000/μL on 2 occasions more than 5 days apart in the 15 days before randomization
  5. * Have adequate liver, renal, and hematologic functions as defined by a table
  6. * Are willing to follow contraception requirements
  1. * Have a history of any thrombotic or embolic event within 12 months before screening
  2. * Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization
  3. * Have significant cardiovascular disease
  4. * Have a diagnosis or history of hematologic malignancy
  5. * Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA)
  6. * Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

Contact Lilly at 1-800-LillyRx (1-800-545-5979)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Stanford University
Stanford, California, 94305-5406
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61614
United States
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
Texas Oncology-Central Austin
Austin, Texas, 78705
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology Gulf Coast
The Woodlands, Texas, 77380
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2027-02

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • Immune Thrombocytopenia (ITP)