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Oral LOXO-305 for Chronic Lymphocytic Leukemia
Study Summary
This trial is testing a new drug for people with leukemia or lymphoma who have failed other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I do not have any ongoing serious infections.I haven't had a heart attack or uncontrolled heart issues in the last 6 months.I have been treated with pirtobrutinib before.I need warfarin for blood clot treatment.I can take care of myself and am up and about more than half of the day.I can take medication by mouth.I am not taking strong medications that affect liver enzymes or drug transporters.I had a severe allergic reaction to rituximab that made me stop taking it.I haven't had a stem cell transplant or CAR-T therapy in the last 60 days.I have CLL/SLL, WM, or NHL and cannot tolerate at least 2 treatments or have had a BTK inhibitor.You cannot participate if you have HIV, and if your HIV status is unknown, a test will be done to make sure it's negative before you can join the study.I have previously been treated with venetoclax or similar medications.I have not had major surgery in the last 4 weeks.I don't have lasting side effects from previous treatments, except for hair loss.You had a serious allergic reaction to rituximab in the past.My CLL has returned, and I haven't been treated with venetoclax before.I am willing to use effective birth control methods.I have another cancer but it's in remission and I'm expected to live more than 2 years.You are allergic to any part of pirtobrutinib.I have a severe nutrient absorption problem.I have an autoimmune blood condition that hasn't been stable in the last 4 weeks.My liver and kidneys are working well.I haven't taken any cancer drugs or investigational agents recently.I received targeted radiation for symptom relief within the last week.My anemia or low platelet count improves with blood transfusions.My CLL has returned or didn't respond to treatment, and I haven't used venetoclax before.My lymphoma has spread to my brain or spinal cord, but I'm stable after treatment.My blood counts are within a healthy range.
- Group 1: Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)
- Group 2: Phase 2 (Pirtobrutinib Monotherapy) Cohort 4
- Group 3: Phase 2 (Pirtobrutinib Monotherapy) Cohort 2
- Group 4: Phase 2 (Pirtobrutinib Monotherapy) Cohort 3
- Group 5: Phase 2 (Pirtobrutinib Monotherapy) Cohort 1
- Group 6: Phase 2 (Pirtobrutinib Monotherapy) Cohort 6
- Group 7: Phase I Dose Escalation (Pirtobrutinib Monotherapy)
- Group 8: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A
- Group 9: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
- Group 10: Phase 2 (Pirtobrutinib Monotherapy) Cohort 5
- Group 11: Phase 2 (Pirtobrutinib Monotherapy) Cohort 7
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we still able to take in participants for this experiment?
"According to the online database clinicaltrials.gov, this study is still recruiting patients. The initial posting for the trial was on 11/16/2018, with the most recent update being on 8/15/2022."
What are researchers hoping to discover through this clinical trial?
"This clinical trial, sponsored by Eli Lilly and Company, is assessing the safety of LOXO-305 in combination with venetoclax (Arm A) over a period of 24 months. The primary outcome measure will be the incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0. Additionally, the trial will evaluate secondary outcomes including the safety profile and tolerability of LOXO-305 (including acute and chronic toxicities), overall response rate (ORR), and other measures of anti-tumor activity."
Is this research project conducted in multiple states?
"There are a number of renowned hospitals and medical centres participating in this clinical trial, such as Northwestern University in Chicago, Smilow Cancer Hospital at Yale-New Haven in New Haven, and Scripps Coastal Medical Center in San Diego. There are 47 locations total."
What are the primary purposes that LOXO-305 is taken for?
"LOXO-305 is an option for treating diffuse large b-cell lymphoma (DLBCL), B-cell lymphomas, and polyangiitis."
How many people are you looking for in this clinical trial?
"That is accurate. The trial's listing on clinicaltrials.gov indicates that it is actively recruiting patients. 860 individuals are needed for the study, which has 47 different enrolment sites across the United States of America."
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