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ME-401 + R-CHOP for Non-Hodgkin's Lymphoma
Study Summary
This trial is testing whether ME-401 can help treat diffuse large B-cell lymphoma (DLBCL). Standard treatment (R-CHOP) can cure many patients, but the cancer returns in about half of them. The trial will combine ME-401 with R-CHOP. Part 1 (phase I) will find the safest dose of ME-401 to use. Part 2 (phase 2) will use that dose to see if it decreases the rate of cancer recurrence.
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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- I do not have uncontrolled immune-related blood disorders.I am currently experiencing lung inflammation due to medication.My cancer has spread to two or more areas outside the lymph nodes.My kidneys are functioning well enough, with a creatinine clearance of at least 45 mL/min.I can care for myself but might not be able to do all my usual activities if it's due to my DLBCL.My white blood cell count is healthy or low due to my lymphoma.My lymphoma has spread to my brain or spinal cord, or I'm at high risk for it.My blood, liver, and kidney functions are all within normal ranges.I am HIV-positive and not on antiretroviral therapy.I haven't had cancer in the last 3 years, except for certain skin cancers, cervical cancer, or low-risk prostate cancer that was treated.My white blood cell count is at least 1,000, unless due to my lymphoma.My hemoglobin level is at least 9.0g/dl, unless my low blood count is due to my lymphoma.My cancer has spread to more than one area outside of the lymph nodes.I have a tumor that can be measured on scans.I am not pregnant or breastfeeding.I've had a short treatment for B-cell lymphoma before joining this study.I am 60 years old or older.I have hepatitis B with a detectable viral load, or I'm on preventive treatment with a non-detectable viral load.I am not pregnant or will use effective birth control during and after the study.I am not pregnant or will use reliable birth control during and after the study.I do not have severe heart failure or recent heart attacks.I need assistance with my daily activities.I have a history of serious stomach or intestine problems.My platelet count is at least 75,000, unless it's low due to my lymphoma.I've had a short treatment for B-cell lymphoma before joining this study.My lymphoma is at an advanced stage (III or IV).I do not have any uncontrolled illnesses like severe infections or heart problems.I do not have a stomach or intestine condition that affects my ability to swallow or absorb medication.My heart pumps well, with an ejection fraction of 50% or higher.I have not had major surgery or significant injury in the last 28 days.My cancer is in an advanced stage (Stage III or IV).I need assistance with my daily activities due to my health condition.My platelet count is at least 75,000, unless it's low due to my lymphoma.I have not been treated with PI3K or BTK inhibitors.I am 60 years old or older.My lymphoma has changed from a slow-growing type to a more aggressive form.I had rituximab for my low-grade lymphoma over a year ago.My kidneys are functioning well enough for treatment.I have hepatitis C antibodies but no active virus according to PCR tests.I have been diagnosed with diffuse large B-cell lymphoma.I had rituximab for my low-grade lymphoma over a year ago.My hemoglobin level is at least 9.0g/dl, or my anemia is due to DLBCL.My lymphoma has changed from a slow-growing type to a more aggressive form.My heart pumps well, with an ejection fraction of 50% or higher.
- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: ME-401 + R-CHOP
Frequently Asked Questions
How many subjects are enrolled in this clinical trial?
"That is correct, the trial information available on clinicaltrials.gov does show that the study investigators are currently looking for participants. The 54 patients needed for this trial will be recruited from a single location."
Are there any more patients being accepted into this trial?
"This research is currently looking for individuals that fit the study's requirements. The listing was first put on clinicaltrials.gov on April 28th, 2021 and updated February 2nd, 2022."
How is ME-401 most commonly used?
"ME-401 is most commonly used to target and treat lung cancer, but it can also be employed against other conditions such as small cell lung cancer (sclc), thyroiditis, or polyangium."
What other research studies have there been on ME-401?
"As of right now, there are a total of 1483 different clinical trials underway that are researching ME-401. Of these studies, 317 have progressed to Phase 3 testing. Even though the majority of research for ME-401 is based in Bethesda, Maryland, there are 51872 locations where studies related to ME-401 are taking place."
What do researchers hope to learn from this study?
"The primary goal of this trial, which will be measured over a 24 month period after treatment, is progression-free survival as assessed by the Lugano criteria. Additionally, researchers are looking at secondary outcomes including duration of response and time to treatment failure."
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