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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, LOXO-338, to treat advanced blood cancer in patients who haven't responded to standard treatments. If effective alone, it will also be tested with another drug, pirtobrutinib, to see if the combination works better.
Who is the study for?
This trial is for US residents with advanced B-cell blood cancers who've had prior therapy, are in good physical condition (ECOG PS 0-1), and have a life expectancy of at least 12 weeks. They must be able to swallow pills, follow the study's outpatient requirements, and use effective birth control if necessary. Exclusions include certain lymphomas, CNS involvement, HIV positivity, recent major surgery or live vaccines, high-dose steroid use within a week of starting treatment, pregnancy or lactation.
What is being tested?
The trial is testing LOXO-338's safety and effectiveness in treating various types of advanced blood cancers over approximately three years. Some patients may also receive Pirtobrutinib as part of their treatment regimen. The goal is to determine how well these drugs work after standard treatments have been tried.
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer medications like LOXO-338 could include nausea, fatigue, diarrhea or constipation; risk of infection; liver function changes; allergic reactions; and possibly low blood cell counts leading to bleeding or anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1 - To determine the effect of LOXO-338 on response rates
Part 1 - To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of oral LOXO-338
Part 2 - To determine the safety and tolerability of LOXO-338 when given in combination with pirtobrutinib
Secondary study objectives
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on duration of response (DOR)
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on overall response rate (ORR)
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on progression-free survival (PFS)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: LOXO-338 + Pirtobrutinib (Combination)Experimental Treatment2 Interventions
LOXO-338 administered orally in combination with pirtobrutinib
Group II: LOXO-338 (Monotherapy)Experimental Treatment1 Intervention
LOXO-338 administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,706 Total Patients Enrolled
40 Trials studying Lymphoma
6,693 Patients Enrolled for Lymphoma
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,744 Total Patients Enrolled
9 Trials studying Lymphoma
3,446 Patients Enrolled for Lymphoma
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,331 Total Patients Enrolled
13 Trials studying Lymphoma
2,036 Patients Enrolled for Lymphoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had AL amyloidosis in the past.You have had diffuse large B-cell lymphoma in the past.You have had lymphoblastic lymphoma or leukemia in the past.You have a history of a certain type of disorder that can happen after an organ transplant.You have a known or suspected history of brain or spinal cord involvement.You have HIV, no matter what your CD4 count is.If you have AL Amyloidosis, you have been diagnosed with symptomatic multiple myeloma in the past or currently have it.You have taken a high dose of prednisone or a similar steroid in the past week.Your heart's QT interval, when adjusted for your heart rate, is longer than 470 milliseconds.You have a serious heart condition.You currently have a hepatitis B or C infection that is not under control.If you have AL amyloidosis, you are excluded if your heart failure is caused by blocked heart arteries.Your blood pressure is too low when lying down or you feel dizzy when standing up, without being dehydrated.If you have AL amyloidosis, your NT-proBNP level is higher than 8500 ng/L, or your BNP level is higher than 700 ng/L if NT-proBNP testing is not available.You must have a type of cancer that starts in your B-cells.You have received treatment before.You are currently taking strong permeability glycoprotein (P-gp) inhibitors.You are able to perform daily activities without any major issues.You are expected to live for at least 12 more weeks.Your kidneys work well enough to clear at least 60 milliliters of creatinine per minute.Any side effects from previous treatments must have improved to a mild level or the same as before treatment, except for hair loss.If you have AL amyloidosis, you must have a way to measure the disease.You had cancer in the last 5 years, except for certain types like basal cell carcinoma and squamous cell carcinoma.You have a history of specific types of lymphoma or leukemia.You have a history of low grade lymphoma that has changed into a different type.You had a stem cell transplant or CAR-T therapy in the last 60 days.You are unable to take certain medications that lower uric acid levels.You are currently getting treatment for cancer.You are currently taking strong medications that affect the way other drugs work in your body.You have a serious problem absorbing nutrients from food.You need to take warfarin for blood thinning.You are allergic to any part of the pirtobrutinib medication.You have had any type of lymphatic system disorder in the past.You have had a cancer that was actively growing.You have had Burkitt or Burkitt-like lymphoma in the past.You have been diagnosed with multiple myeloma in the past.You currently have another type of cancer that could affect the evaluation of the study treatment's safety.You have another serious health problem that is not being controlled.You have a type of autoimmune disease that affects your blood cells and it is not under control.If you are joining the second part of the study for the drugs LOXO-338 and pirtobrutinib, you should not have experienced worsening of your condition or had bad reactions to pirtobrutinib before.If you have a history of heart attack or heart failure, and your heart's pumping ability is less than 45% in the year before starting the study, you cannot participate.You have a history of serious or uncontrolled heart rhythm problems while taking a previous BTK inhibitor.You have had serious bleeding while taking a previous BTK inhibitor.Your bone marrow works well.Your liver is working well.
Research Study Groups:
This trial has the following groups:- Group 1: LOXO-338 (Monotherapy)
- Group 2: LOXO-338 + Pirtobrutinib (Combination)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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