ME-401 for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering, Harrison, NY
Leukemia, Lymphocytic, Chronic, B-Cell+13 More
ME-401 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Lymphocytic, Chronic, B-Cell

Study Summary

This study is evaluating whether a drug called ME-401 may help treat certain types of leukemia.

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Eligible Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Diffuse
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Small Lymphocytic Lymphoma
  • Follicular Lymphoma ( FL)
  • Mantle Cell Lymphoma (MCL)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Lymphoma, Non-Hodgkin
  • Marginal Zone B Cell Lymphoma)
  • High Grade Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ME-401 will improve 7 primary outcomes and 10 secondary outcomes in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of within the first 56 days.

1 year
Determine the MTD of ME-401 plus zanubrutinib
Evaluate the safety and tolerability of ME-401 plus rituximab
Evaluate the safety and tolerability of ME-401 plus zanubrutinib
Maximally Tolerated Dose (MTD) of ME-401 alone
Minimum Biologically Effective Dose (mBED) of ME-401 alone
Safety profile of ME-401 alone
2 years
Efficacy of ME-401 alone as assessed by (OR)
Efficacy of ME-401 with rituximab
Efficacy of ME-401 with zanubrutinib
Evaluate the (AUC) PK of ME-401 alone
Evaluate the PK (AUC) of ME-401 in combination with zanubrutinib
Evaluate the PK (AUC) of ME-401 with rituximab
Evaluate the PK (Cmax) of ME-401 alone
Evaluate the PK (Cmax) of ME-401 in combination with zanubrutinib
Evaluate the PK (Cmax) of ME-401 with rituximab
Day 56
Determine the DLTs of ME-401 plus zanubrutinib
Dose Limiting Toxicities (DLTs) of ME-401 alone

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
ME-401 in Combination with Rituximab

This trial requires 177 total participants across 3 different treatment groups

This trial involves 3 different treatments. ME-401 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

ME-401 in Combination with RituximabThe second arm is an open label study to evaluate the safety, efficacy, and pharmacokinetics of ME-401 in combination with rituximab in subjects with various B-cell malignancies. There are two planned cohorts which may enroll up to 30 subjects.
ME-401 Alone
Drug
This arm is an open-label, dose escalation study to determine the safety, efficacy and pharmacokinetics of ME-401 along with the mBED, MTD, and DLTs. There are 4 planned cohorts which may enroll up to 61 subjects.
ME-401 in Combination with ZanubrutinibThe third arm is an open label study evaluating the safety, efficacy, MTD, DLT and pharmacokinetics of ME-401 in combination with zanubrutinib in subjects with various B-cell malignancies. This arm will include 2 stages: a safety evaluation stage (cohort of 6-12 subjects) and a disease-specific expansion cohort stage (up to 74 subjects).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Memorial Sloan Kettering - Harrison, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Lymphocytic, Chronic, B-Cell or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL
No prior therapy with PI3Kd inhibitors
No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy or subject had disease progression
Subjects with CLL/SLL must have prior treatment with BTK inhibitor and must have had progression or recurrence while on treatment of within 12 mos from BTK treatment
Subject must have failed at least 1 prior systemic therapy
QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
Left ventricular ejection fraction > 50%
For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion >1.5 cm, as defined by Lugano Classification
Willingness to participate in collection of pharmacokinetic samples
A negative serum pregnancy test within 14 days of study Day 0, for females of childbearing potential

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 leukemia, lymphocytic, chronic, b-cell?

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The cause of chronic, aggressive leukemias has not been clearly defined, though genetic defects in the cells of the bone marrow might be involved. Lymphocytic leukemia and acute leukemias are both chemotherapeutic diseases that are treated by chemotherapy. Lymphoma and leukemium are diseases characterized by a lymphocytic infiltrate in the tissues.

Unverified Answer

How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

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Around 9% of all cases of leukemia, lymphocytic, chronic, b-cell are diagnosed each year in the United States. As a whole, leukemia, lymphocytic, chronic, b-cell affects almost 300,000 persons a year in the United States. Most cases of leukemia, lymphocytic, chronic, b-cell (about 60% of all cases) are diagnosed in male subjects.

Unverified Answer

What are common treatments for leukemia, lymphocytic, chronic, b-cell?

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While some types of leukemia (lymphoid) may respond well to immunosuppressive therapy (such as cyclophosphamide/hydrocortisone/sulfasalazine), the treatment for most leukemia is chemotherapy (such as cytarabine, methotrexate, etoposide, or fludarabine). Also, while some lymphoid leukemias may respond in the initial weeks or months of chemotherapy, most relapse very quickly. A small proportion of lymphoid leukemias may respond to chemotherapy such as methotrexate, mercaptopurine, fludarabine, or amsacrine, in particular the B-cell kinds.

Unverified Answer

Can leukemia, lymphocytic, chronic, b-cell be cured?

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Recent findings is the first, and perhaps only, to employ and compare two different techniques that have been shown by independent investigators to be effective and safe in achieving remission in chronic B-cell leukemias.

Unverified Answer

What is leukemia, lymphocytic, chronic, b-cell?

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A person most commonly becomes ill because of an infection or other disease. About 20 percent of deaths are tied to leukemia and lymphoma. There are specific types of leukemia and lymphoma. In most industrialized countries, cancer as a cause of death is declining because of advances in treatments and in the quality of life. The causes of cancer, lymphoma, and leukemia have not been determined for most of the diseases, so the causes of most forms of cancer, lymphoma, and leukemia are unknown.

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What are the signs of leukemia, lymphocytic, chronic, b-cell?

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When leukemia is diagnosed, the prognosis is poor. The most common symptoms include fatigue, weight loss and swelling hands and feet, swollen adenopathy and malaise. The first symptom to occur is fatigue. The diagnosis can be confirmed by blood tests that indicate the presence of certain blood cell types. Some of the less common symptoms relate to the leukemia type. They include rash, itching or dry skin, and skin lesions such as pimples or other lesions.

Unverified Answer

What is the survival rate for leukemia, lymphocytic, chronic, b-cell?

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Although the overall 5-year survival rate for leukemia, lymphocytic, chronic, and B-cell is 80-85%; the most recent data suggest that survival rates are steadily improving. The most common causes of death in leukemia are relapse, or the growth of cancer cells which have developed resistance or become defective. The most common cause of death in lymphocytic chronic cancers is infection.

Unverified Answer

Have there been any new discoveries for treating leukemia, lymphocytic, chronic, b-cell?

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There has been considerable progress made over the past 20 years in the development of new forms of therapy for leukemia in adults. However, in the treatment of chronic lymphocytic leukemia, the majority of patients with relapsed disease are managed with a single oral drug, pentostatin, in combination with interferon. The use of a combination of cytotoxic agents for myelodiplastic syndromes (treatments for which more than one drug is used) is being investigated. In particular, a study of low-dose vincristine therapy is in progress. In the management of acute myeloid leukemia, therapies used in clinical trials have been developed that are based on the underlying nature of the disease.

Unverified Answer

How quickly does leukemia, lymphocytic, chronic, b-cell spread?

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Listed herein is the order in which leukemia, lymphocytic, chronic, b-cell appears on the bone marrow smear as a result of blood transfusion, aspiration, or aspiration and bone marrow biopsy. This does not correlate with which leukemia will be seen most often in a particular location on the bone marrow or the age of patients. As such, it is not an accurate method of predicting which subtypes of leukemia may appear preferentially in particular areas of the body.

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How serious can leukemia, lymphocytic, chronic, b-cell be?

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Patients with lymphocytic, chronic, B-cell leukemias are at a higher risk of death. Patients with acute lymphocytic leukemia have a higher survival, especially if the disease is in remission (69%). Patients with chronic lymphocytic leukemia are at a higher risk of relapse, even if the disease is in remission (38% in one study). Patients with chronic myeloid leukemia had a higher rate of relapse (22% over several years of treatment).

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Does leukemia, lymphocytic, chronic, b-cell run in families?

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Results from a recent paper demonstrates that in families with B-CLL at least two cases must be present in order to demonstrate an increased frequency of lymphadenopathies, lung, breast and other cancers and skin and/or gut malignancies. These families may experience delays in diagnosing familial B-CLL.

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Has me-401 proven to be more effective than a placebo?

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Results from a recent clinical trial from these studies demonstrate that therapy with me-401 at 2 μg was more effective than that therapy with the placebo. In addition, there were no important differences between the treatments of me-401 and that of the non-me-401 groups. Further studies are required to clarify the precise mechanisms by which me-401 exerts its therapeutic effects.

Unverified Answer
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