Status:
ACTIVE_NOT_RECRUITING
A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Loxo Oncology, Inc.
Conditions:
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04849416
Start Date
May 14 2021
End Date
December 1 2025
Last Update
June 18 2025
Active Locations (22)
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1
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China, 241001
2
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
3
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China, 510515
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 511400