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Completed

NCT Number: NCT04849416

A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

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.

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Key information

Conditions

Leukemia, Lymphoid Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wannan Medical College Yijishan Hospital, Wuhu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOXO-305

Drug

Administered orally.

Other names: LY3527727, Pirtobrutinib

Primary outcomes

  1. Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee

    Time frame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)

    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.

Secondary outcomes

  1. PAS ORR: ORR Assessed by Investigator

    Time frame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)

    ORR was assessed by the Investigator. It was estimated based on the percentage of participants with BOR of CR or PR. Two-sided 95% CI was calculated using the exact binomial distribution.

  2. PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)

    Time frame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)

    BOR was assessed by the IRC and Investigator. Best overall assessment categories include (in descending order of extent of response): CR, PR, SD, PD, and NE. Two-sided 95% CI was calculated using the exact binomial distribution.

  3. PAS: Duration of Response (DOR)

    Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks)

    DOR was assessed by the Investigator and IRC. DOR is defined as the number of months from the date of the first documented response to the date of PD or death, whichever occurs earlier. Participants who are alive and without documented PD as of data analysis cutoff date will be censored.

  4. PAS: Progression Free Survival (PFS)

    Time frame: Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks)

    PFS was assessed by the IRC and Investigator. PFS is defined as the number of months from the date of the first dose of study drug to the earlier of documented PD or death due to any cause. Participants who are alive and without documented PD as of data analysis cutoff date were censored.

  5. PAS: Overall Survival (OS)

    Time frame: Date of First Dose to Date of Death from Any Cause (Up to 100 weeks)

    OS is defined as the number of months elapsed between the date of the first dose of study drug and the date of death from any cause. Participants who are alive or lost to follow-up as of the data cutoff date will be censored.

  6. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305

    Time frame: Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.

    PK: AUC[0-tlast] of LOXO-305

  7. PK: Maximum Concentration (Cmax) of LOXO-305

    Time frame: Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.

    PK: Cmax of LOXO-305

  8. PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Time frame: Baseline, 7 Days After Treatment Discontinuation (Up To 100 Weeks)

    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Apr 19, 2021
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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