CLINICAL TRIAL

MT-401 for Leukemia

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18+ · All Sexes · New Haven, CT

This study is evaluating whether a type of white blood cell called a T-cell may help treat acute myeloid leukemia.

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About the trial for Leukemia

Eligible Conditions
Acute Myeloid Leukemia (AML) · Leukemia, Myeloid · Leukemia · Leukemia, Myeloid, Acute · Transplantation, Stem Cell

Treatment Groups

This trial involves 2 different treatments. MT-401 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
MT-401
DRUG
Experimental Group 2
MT-401
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia or one of the other 4 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:
Creatinine clearance is a measure of how well the kidneys are working show original
Adjuvant therapy for AML (Group 1) at 90 days post-HSCT is defined as patients with CRMRD; or First relapse post-HSCT (MRD+ or frank relapse). show original
will be treated with a conditioning regimen of Arm 2A (SOC) Patients in Arm 1B who experience a relapse post-HSCT will be treated with a conditioning regimen of Arm 2A. show original
receive safety lead-in dose Patients who fit all the criteria for Group 2 only receive safety lead-in dose. show original
Are ≥18 years of age
A person has a Karnofsky/Lansky score of ≥60 if their score is 60 or higher. show original
This means that a person can expect to live for at least 12 weeks. show original
Adequate blood, liver, and renal function
A person's blood is strong if it has a hemoglobin level of 7.0 grams or more per deciliter show original
The liver is functioning normally if the bilirubin level is 2 times the upper limit of normal or less, and the aspartate aminotransferase level is 3 times the upper limit of normal or less. 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: Up to 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 24 months.
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 MT-401 will improve 3 primary outcomes in patients with Leukemia. Measurement will happen over the course of Baseline through Cycle 1 (28 Days).

Safety Lead-In
BASELINE THROUGH CYCLE 1 (28 DAYS)
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
BASELINE THROUGH CYCLE 1 (28 DAYS)
Phase 2 Adjuvant Group
UP TO 24 MONTHS AFTER THE FIRST PARTICIPANT IS RANDOMIZED
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
UP TO 24 MONTHS AFTER THE FIRST PARTICIPANT IS RANDOMIZED
Phase 2 Active Disease Group
UP TO 24 MONTHS
Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause
UP TO 24 MONTHS

Patient Q & A Section

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

Can leukemia be cured?

It is not medically possible to cure CLL or AML. Many variables are involved, but the results depend on the leukemia type. When cure is sought, it is usually within the scope of the clinical and scientific community to advise the patient that the illness appears incurable, even though a significant minority of patients respond to treatment options.

Anonymous Patient Answer

What are the signs of leukemia?

Some signs and symptoms of leukemia include malaise, a high white blood count, loss of appetite, and fatigue. Fever may be the most specific sign of leukemia. Other symptoms may signify other types of cancers. Lymphopenia and anemia are common and have led to anemia. Abnormal liver function can show signs of liver cancer. Many other diseases can have similar signs and symptoms and should be evaluated. These include hepatitis, gastrointestinal and skin diseases, and kidney disease.

Anonymous Patient Answer

What are common treatments for leukemia?

Most patients with leukemia receive intensive chemotherapy to achieve prolonged remission. Patients who experience a relapse or have a poor prognosis receive chemotherapy again or receive an autologous stem cell transplant. Radiation therapy plays a less important role in leukemia treatment and is only used in certain patients.

Anonymous Patient Answer

What causes leukemia?

Leukemia is caused by mutations in chromosomal DNA of the blood-forming stem and progenitor cells, rather than from oncoviruses or other exogenous agents. These cells may become transformed, as they divide, leading to the development of leukemias. This presents a problem in the diagnosis of leukemia, because the malignant cells that dominate the leukemia may not be infected by an agent; for example, acute leukemia may develop when a person's lymphocytes are mutated by a toxin, or chronic leukemia may develop when stem cells are mutated by a virus.

Anonymous Patient Answer

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

Each year, about 26.6 million people in the USA will be diagnosed with leukemia. This makes it the second most common lethal cancer in the US after lung cancer...

Anonymous Patient Answer

What is leukemia?

Leukemia is a cancer of the blood platelets, bone marrow, liver or lymphatic system. It can occur in adults (18-40 years) or children and adolescents, but most cases occur in adults.

Anonymous Patient Answer

What are the chances of developing leukemia?

The chances of getting leukemia increase as a person gets older. This effect is particularly prominent among males older than 80 years of age. The reason for this increase is not known. However, it is likely that it is linked to some environmental or lifestyle factor that becomes exposed to an increased frequency in older persons.

Anonymous Patient Answer

What does mt-401 usually treat?

It does not kill the tumors but may shrink tumor tissue and prevent future growth by depriving it of certain essential nutrients. It boosts cell growth and tumor growth in part by activating the IGF1 signaling pathway at certain tumor sites, but also at distant sites. It also activates this pathway at a variety of tumor sites. In human preclinical models, it was well tolerated but had only minor activity. None are currently in phase III clinical trials but as of February 2019, there are indications that the drug has been discontinued.\n\nIn 2013, Dr.

Anonymous Patient Answer

What is the survival rate for leukemia?

There is significant variation in the survival rates of individuals with all CLL and CML, especially in those with early disease. Overall survival in CLL is better than the general population, and survival rates are similar for males and females. Survival in CML is shorter than general life expectancy. Overall survival for both CLL and CML are greater than 10 years, the current limit for remission of CLL or CML.

Anonymous Patient Answer

How quickly does leukemia spread?

Patients with primary CLL or [hairy cell leukemia](https://www.withpower.com/clinical-trials/hairy-cell-leukemia) (a rare type of leukemia) who went into complete remission from their diagnosis to the time of relapse showed the fastest rate of disease progression (on average, 11.8 months) and had the most progressive leukemia, including the leukemia cells in the bone marrow and blood, compared with those of the remaining patients. A significant factor influencing the progression of leukemia is the severity of the disease when detected. Patients with newly diagnosed chronic stage 2 or even acute stage 1 disease had the shortest average progression times (3.1 and 9.6 months, respectively). The progression times after the initial diagnosis of chronic B-cell illnesses were the slowest (5.

Anonymous Patient Answer

What is the average age someone gets leukemia?

From the data that has been collected in various countries, the average age of diagnosis seems to be 52 years. Findings from a recent study the gender ratio of patients is slightly less than half, which is approximately the ratio that is seen in the population

Anonymous Patient Answer

Who should consider clinical trials for leukemia?

Patients are a good cohort of physicians to recruit for clinical trials. It is particularly important for a trial to include a population that is not being treated by other physicians in order to avoid skewing data towards results based on convenience rather than research. Once a trial has recruited enough patients, it may be reasonable to ask patients to donate blood before taking part in the study. When this is not possible or advisable, it may be acceptable to ask that patients return annually for blood donation as part of the study.

Anonymous Patient Answer
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