CLINICAL TRIAL

ME-401 for Lymphoma

Newly Diagnosed
Stage III
Recruiting · 18+ · All Sexes · Cleveland, OH

This study is evaluating whether a drug called ME-401 may help patients with diffuse large b-cell lymphoma.

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About the trial for Lymphoma

Eligible Conditions
Lymphoma · Diffuse Large B-Cell Lymphoma (DLBCL) · Lymphoma, Large B-Cell, Diffuse · Lymphoma, B-Cell

Treatment Groups

This trial involves 2 different treatments. ME-401 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Vincristine
DRUG
Cyclophosphamide
DRUG
Rituximab
DRUG
ME-401
DRUG
Prednisone
DRUG
Doxorubicin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved
Cyclophosphamide
FDA approved
Rituximab
FDA approved
Prednisone
FDA approved
Doxorubicin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lymphoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
If a person's performance status is ≤2, then they will be accepted into the study even if they have DLBCL complications, as long as they are expected to improve once they start therapy show original
If bilirubin levels are lower than 2.0 times the upper limit of normal (ULN), except when caused by Gilbert's syndrome (in which case levels can be up to 3 times the ULN), then the patient is considered to have a normal bilirubin level. show original
Hemoglobin must be at least 9.0 grams per deciliter unless the anemia is clearly due to DLBCL show original
A person has absolute neutrophil count of 1,000/mcL or higher, unless the person's neutropenia is clearly due to DLBCL show original
Participants must have histologically confirmed diffuse large B-cell lymphoma (DLBCL) show original
People enrolled in the phase II part of the study can receive brief (<15 days) treatment with glucocorticoids (maximum dose of prednisone 40 mg) and/or one cycle of chemotherapy, like R-CHOP, if they had all necessary staging tests done prior to R-CHOP or steroids, including CT and/or PET/CT scans, and bone marrow biopsy show original
(Version 2009) The participants must have radiographically measurable disease show original
is required No prior therapy with PI3K inhibitors or BTK inhibitors is needed. show original
--If you have had low grade lymphoma for at least 12 months and have only received a single dose of rituximab, you may be eligible to participate in this study. show original
The patient's platelet count must be at least 75,000/mcl, unless it is clear that the thrombocytopenia is due to DLBCL show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 36 months (3 years) after completion of therapy or until death, whichever comes first
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months (3 years) after completion of therapy or until death, whichever comes first
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 36 months (3 years) after completion of therapy or until death, whichever comes first.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ME-401 will improve 2 primary outcomes and 9 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Up to 24 months after treatment.

Number of treatment-related AEs in Phase I
UP TO 24 MONTHS AFTER TREATMENT
Number of treatment-related AEs in Phase I. Participants will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause with a cut off of 24 months after completion of therapy.
UP TO 24 MONTHS AFTER TREATMENT
Number of treatment-related AEs in Phase II
UP TO 24 MONTHS AFTER TREATMENT
Number of treatment-related AEs in Phase II Participants will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause with a cut off of 24 months after completion of therapy.
UP TO 24 MONTHS AFTER TREATMENT
Number of days treatment is delayed
UP TO 24 MONTHS AFTER TREATMENT
Number of days treatment is delayed
UP TO 24 MONTHS AFTER TREATMENT
Number of clinically significant non-hematologic grade 3 or 4 treatment-related AEs or hematologic grade 3 or 4 treatment related AEs
UP TO 24 MONTHS AFTER TREATMENT
Dose limiting toxicity (DLT) as defined by non-hematologic clinically significant grade 3 or 4 treatment-related AEs or hematologic grade 3 or 4 treatment related AEs that are clinically significant during the first cycle, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
UP TO 24 MONTHS AFTER TREATMENT
Complete Response (CR) assessed by Lugano criteria
36 MONTHS (3 YEARS) AFTER COMPLETION OF THERAPY OR UNTIL DEATH, WHICHEVER COMES FIRST
CR assessed by Lugano criteria
36 MONTHS (3 YEARS) AFTER COMPLETION OF THERAPY OR UNTIL DEATH, WHICHEVER COMES FIRST
Duration of Response (DoR)
36 MONTHS (3 YEARS) AFTER COMPLETION OF THERAPY OR UNTIL DEATH, WHICHEVER COMES FIRST
DoR defined as the time from documented response (CR or PR) to the time of confirmed disease progression or death due to any cause, whichever occurs first
36 MONTHS (3 YEARS) AFTER COMPLETION OF THERAPY OR UNTIL DEATH, WHICHEVER COMES FIRST
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes lymphoma?

The two major types of lymphoma: B cell lymphomas and T cell lymphomas are associated with different factors. Many risk factors for Lymphoma have been identified, and even a few have been associated with specific types of Lymphoma in a number of different studies. These factors also vary between geographic areas.

Anonymous Patient Answer

How many people get lymphoma a year in the United States?

About 11 million cases of non-Hodgkin lymphoma are diagnosed every year in the United States, making it the fourth most common cancer in American men. However, the number of American lymphoma patients who die each year is approximately 200,000, or about 9.5 percent of the number of American lymphoma patients diagnosed annually.

Anonymous Patient Answer

What are the signs of lymphoma?

Lymphoma is often asymptomatic; common signs include enlargement, firmness, and/or pain of a lymph node. A lump on the neck or armpit, skin changes such as rashes and swelling, unexplained fever, swelling in the groin and/or lower leg, and loss of appetite are the most common signs of non-Hodgkin's lymphoma.

Anonymous Patient Answer

What is lymphoma?

Lymphoma was coined from Lymphatic tissue. Lymphatic tissue comes from Venous tissue and is formed by a single layer of cells known as cells of Lymphatic tissue that are connected through tight junctions. The cells that make up the tight junctions of the cells are called tight junctions (TJ) proteins. TJ proteins are a major part of the inner lining of the gut and other body parts. The TJ proteins may be either part of the membrane or in the sub-apical organelle.

Anonymous Patient Answer

What are common treatments for lymphoma?

A variety of chemotherapy agents can be used to treat lymphoma. Most current treatments have an overall improvement in survival in patients with lymphoma. However, as survival is contingent upon the type of disease, patient age, and individual attributes, there can be a significant variation among patient populations. For most patients with lymphoma, treatment and chemotherapy are the best means of managing and preventing symptoms.\n

Anonymous Patient Answer

Can lymphoma be cured?

It is a question of time. There is no single cure at present for lymphoma. There is no proof of remission for non-Hodgkin's lymphoma (NHL) for >15% of patients. If remission can be defined as long-term stable disease, about 70% of all patients achieving remission with any combination of treatment. There are many curative treatments, and as treatments persist and new therapies become developed a cure may happen.

Anonymous Patient Answer

What is the survival rate for lymphoma?

Overall survival and the cause of death in cancer patients have been shown to be heavily influenced by multiple factors (e.g. gender, general physical health) that are outside the control of the doctor. There is no need to have an accurate knowledge of the survival rates for lymphoma. The main challenge is to provide the necessary treatment based on each patient (cancer site, age, general physical health) to be able to prolong, if possible, a minimal life span.

Anonymous Patient Answer

What are the chances of developing lymphoma?

The odds increases with age (over 70) and are highest among those with rheumatoid arthritis, diabetes mellitus, hypertension, and/or smoking, and among those with a close family history of cancer.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma?

Lymphoma affects about 6,000 people in the UK every year. A better understanding of lymphoma will allow us to find better, more targeted treatments that will hopefully result in less pain and more chances of a full, long-term remission.

Anonymous Patient Answer

Who should consider clinical trials for lymphoma?

Cancer patients are generally in a very desperate situation and there are many uncertainties and uncertainties inherent in their conditions. In most cases, clinical trials can be considered. Results from a recent clinical trial can be considered for the benefit of the patient. Clinical trials can result in treatment that will not have a large benefit based on results. If the risk of treatment outweighs any benefit, then treatment without the trials should be considered. Some of our data suggests that trials are not necessarily useless, but, by not offering treatment in trials, patients are better placed to receive a more optimal treatment without a trial. The study authors would like this article to serve for others to consider the potential outcomes of clinical trials and evaluate them without a specific patient's treatment.

Anonymous Patient Answer

What is me-401?

Results from a recent paper provides valuable data to support the application of M-401 for the treatment of relapsed follicular lymphoma and chronic lymphocytic leukemia patients after intensive chemotherapy. M-401 showed excellent efficacy in the treatment, and its therapeutic action, safety profile, and tolerability of M-401 indicate its clinical utility for the treatment of follicular lymphoma and chronic lymphocytic leukemia.

Anonymous Patient Answer

What is the primary cause of lymphoma?

Results from a recent clinical trial reveals that most patients with lymphoma received chemotherapy. The use of chemotherapy was associated with lymph node involvement in the testis (p<0.001). Results from a recent clinical trial showed that chemotherapy is a significant cause of lymphoma in Japan.

Anonymous Patient Answer
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