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)

  • STATUS
    Recruiting
  • End date
    Apr 19, 2025
  • participants needed
    126
  • sponsor
    Eli Lilly and Company
Updated on 17 September 2022
renal function
cancer
tyrosine
lymphoma
leukemia
mantle cell lymphoma
renal function tests
btk inhibitor

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.

Details
Condition Leukemia, Lymphoid, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell
Treatment LOXO-305
Clinical Study IdentifierNCT04849416
SponsorEli Lilly and Company
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

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
Eastern Cooperative Oncology Group 0-2
least 1 indication for treatment consistent with IWCLL 2018 criteria is
required
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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