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Study Summary
This trial is testing a new drug to see if it's safe and effective for treating advanced blood cancer in patients who have already tried other treatments.
- Waldenstrom Macroglobulinemia
- Chronic B-Cell Leukemia
- Mantle Cell Lymphoma
- Multiple Myeloma
- Marginal Zone Lymphoma
- Non-Hodgkin's Lymphoma
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?
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- 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.
- Group 1: LOXO-338 (Monotherapy)
- Group 2: LOXO-338 + Pirtobrutinib (Combination)
- 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
Has LOXO-338 achieved regulatory authorization from the FDA?
"Considering the preliminary nature of this Phase 1 trial, LOXO-338 has been rated a '1' on our safety scale. This rating is reflective of limited data surrounding its efficacy and security."
What is the sample size for this research project?
"A total of 316 eligible participants are required for the successful completion of this trial, which is being conducted by Loxo Oncology Inc. in numerous locations throughout the USA - such as City of Hope National Medical Center (Duarte, Minnesota) and Mayo Clinic (Rochester, New york)."
Is access to this research currently accessible for participants?
"This medical investigation is actively seeking participants. The trial was initially posted on September 30th 2021 and the information has been recently updated as of October 11th 2022."
How many sites are actively overseeing the trial?
"The medical trial is being offered to patients at City of Hope National Medical Centre in Duarte, Minnesota, Mayo Clinic located in Rochester, New york and University California San Francisco. Additionally, it's available at 12 other sites throughout the USA."
What are the primary goals of this experimental endeavor?
"Per the principal investigator, Loxo Oncology, Inc., this trial's primary purpose will be evaluated within a 28-day cycle. Specifically, they aim to assess how LOXO-338 impacts response rates and preliminary antitumor activity based on time-to-progression (TTP). Additionally, secondary objectives include characterizing its pharmacokinetic properties through measuring Area Under Curve (AUC) and Maximum Drug Concentration (Cmax)."
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