Clinical trial · Interventional
A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)
A Phase 2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)
NCT04849416CI-TRIAL-00102657completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Lymphoid | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, B-Cell, Marginal Zone | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LOXO-305 | Drug | Pirtobrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LOXO-305
- description
- Participants received 200 mg of LOXO-305 administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
- interventionNames
- Drug: LOXO-305
Primary outcomes (1)
- measure
- Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee
- timeFrame
- Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
- description
- ORR was assessed by an Independent Review Committee (IRC). It was estimated based on the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Two-sided 95% CI was calculated using the exact binomial distribution. PAS consisted of participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Participants with histologically confirmed B-cell malignancy including: * Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen; * CLL/SLL treated with a prior BTK inhibitor containing regimen; * Other types of B-cell NHL * All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required * Eastern Cooperative Oncology Group 0-2 * Adequate hematologic status, coagulation, hepatic and renal function Exclusion Criteria * Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment * Participants requiring therapeutic anticoagulation with warfarin * Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded * Significant cardiovascular disease * Prolongation of the QT interval * Test positive for human immunodeficiency virus (HIV) * Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors * Pregnancy or lactation * Active second malignancy * Prior treatment with LOXO-305 * Known hypersensitivity to any component or excipient of LOXO-305
References
Publications (1)
- DERIVEDLiu Y, Lin N, Yi S, Huang H, Guo Y, Zhang Q, Yang H, Zhang H, Zhang L, Feng R, Qian Y, Zhu J, Song Y, Zhu J. Pirtobrutinib in Chinese patients with relapsed or refractory B-cell malignancies: A single-arm, open-label, phase 2, multicenter trial. Int J Cancer. 2025 Jun 1;156(11):2158-2168. doi: 10.1002/ijc.35339. Epub 2025 Feb 28. PMID 40018797