Pirtobrutinib for adults with primary immune thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The phase 1 portion uses a dose‑escalation design to define tolerability, safety, and pharmacokinetics with blood sampling to measure drug levels and elimination. The phase 2 portion randomizes participants to multiple pirtobrutinib doses or placebo to compare effects on platelet counts and overall safety over about 28 weeks. Participants are adults with primary ITP who are relapsed or treatment‑resistant and meet laboratory and organ‑function criteria. The study is sponsored by Eli Lilly and is being conducted at three U.S. academic centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process
* 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
* Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
* Have a platelet count less than 30,000/μL on 2 occasions at least 5 days apart in the 15 days before randomization
* Have adequate liver, renal, and hematologic functions as defined by a table
* Are willing to follow contraception requirements

Exclusion Criteria:

* Have a history of any thrombotic or embolic event within 12 months before screening
* Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization
* Have significant cardiovascular disease
* Have a diagnosis or history of hematologic malignancy
* 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)
* Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)

Where it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• MedStar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Ochsner Clinic Foundation
  New Orleans, Louisiana, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Texas Oncology - Central South
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Thiotepa with pirtobrutinib and sintilimab for frail or relapsed/refractory CNS lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.