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)
2 other identifiers
interventional
87
1 country
22
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 four years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2021
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedResults Posted
Study results publicly available
July 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2025
CompletedFebruary 6, 2026
August 1, 2025
1.9 years
April 16, 2021
April 6, 2024
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee
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.
Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
Secondary Outcomes (8)
PAS ORR: ORR Assessed by Investigator
Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
PAS: Duration of Response (DOR)
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks)
PAS: Progression Free Survival (PFS)
Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks)
PAS: Overall Survival (OS)
Date of First Dose to Date of Death from Any Cause (Up to 100 weeks)
- +3 more secondary outcomes
Study Arms (1)
LOXO-305
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Loxo Oncology, Inc.collaborator
Study Sites (22)
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, 241001, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 511400, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 71066, China
Xingtai People's Hospital
Xingtai, Hebei, 054031, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215066, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710126, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi, Xinjiang, 830000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Shanghai East Hospital
Shanghai, 200120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2021
First Posted
April 19, 2021
Study Start
May 14, 2021
Primary Completion
April 10, 2023
Study Completion
December 29, 2025
Last Updated
February 6, 2026
Results First Posted
July 16, 2024
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
- Access Criteria
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting