NX-2127 for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN
Leukemia, Lymphocytic, Chronic, B-Cell+12 More
NX-2127 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Lymphocytic, Chronic, B-Cell

Study Summary

This study is evaluating whether a drug may help treat certain types of cancer.

See full description

Eligible Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Waldenstrom Macroglobulinemia
  • Lymphoma
  • Lymphoma, Mantle-Cell
  • Cancer
  • Lymphoma, Large B-Cell, Diffuse
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Follicular Lymphoma ( FL)
  • Neoplasms
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma
  • Waldenström's Macroglobulinemia (WM)
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphoma (MZL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether NX-2127 will improve 4 primary outcomes and 6 secondary outcomes in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of 10 months.

10 months
Number of Participants with Protocol Specified Dose-Limiting Toxicities
To establish the MTD and/or recommended Phase 1b dose of NX-2127
Up to 24 months
Overall survival (OS) as assessed by the Investigator
To evaluate the clinical activity of NX-2127 at the recommended Phase 1b dose based on overall response rate (ORR) as assessed by the Investigator
To further evaluate the safety and tolerability of NX-2127 by collecting adverse events, treatment emergent adverse events, and incidence of all deaths
Up to 3 Years
Duration of response (DOR) as assessed by the Investigator
Progression-free survival (PFS) as assessed by the Investigator
Up to 3 years
Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Pharmacokinetic (PK) Profile of NX-2127: Maximum Serum Concentration

Trial Safety

Safety Estimate

1 of 3

Trial Design

6 Treatment Groups

No Control Group
Phase 1a Dose Escalation

This trial requires 130 total participants across 6 different treatment groups

This trial involves 6 different treatments. NX-2127 is the primary treatment being studied. Participants will be divided into 6 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.

Phase 1a Dose Escalation
Drug
Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose
Phase 1b Dose Expansion in BTK C481 mutation-positive CLL/SLL
Drug
BTK C481 mutation-positive CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Phase 1b Dose Expansion in CLL or SLL with no BTK C481 mutation
Drug
CLL/SLL patients with no BTK C481 mutation whose disease has failed treatment with a BTK inhibitor
Phase 1b Dose Expansion in MCL, MZL or WM
Drug
MCL, MZL, or WM patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Phase 1b Dose Expansion in FL
Drug
FL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen
Phase 1b Dose Expansion in DLBCL
Drug
DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and an anthracycline

Trial Logistics

Trial Timeline

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

Closest Location

Sarah Cannon Research Institute at Tennessee Oncology - Nashville, TN

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 12 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:
, is essential for erythropoiesis If a person's organs or bone marrow are not functioning properly, they will not be able to produce red blood cells. show original
Patients who could potentially get pregnant must use contraception for the entire time of the study, as defined by the protocol. show original
Patients with Hodgkin's lymphoma who have experienced a transformation to another form of lymphoma are eligible for the study, with the exception of those who have Richter's transformation, prolymphocytic leukemia, or blastoid lymphoma prior to planned start of study drug. show original
The text states that people with histologically confirmed CLL, SLL, WM, MCL, and MZL, FL (grade 1 - 3b), and DLBCL (High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements and high-grade B-cell lymphoma NOS) are eligible to participate in the study. show original
Patients must be ≥ 18 years of age
A patient must have measurable disease in order to be eligible for treatment according to disease-specific response criteria. show original
NHL patients who have an indolent form of the disease must meet specific criteria in order to be considered for systemic treatment show original
A person with an ECOG performance status of 0 or 1 is considered to be a cancer-free individual. show original
Patients who have received at least two prior systemic therapies (or one prior therapy for patients with WM), and who have no other therapies known to provide clinical benefit. show original
Must require systemic therapy

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, lymphocytic, chronic, b-cell be cured?

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It is not uncommon for leukemia, lymphocytic, chronic, b-cell to recur after a BCT following treatment with induction chemotherapy, and/or maintenance chemotherapy. The likelihood is greatest if the disease does not respond to initial treatment. One review found that recurrence was highly dependent on site, type of leukemia, and if the initial disease had been < 4 cm in diameter. Chemotherapy is more effective for small-sized cancers. The greatest survival is found at the University of Alabama Cancer Center. The goal of therapy is to maximize tumor control so all involved sites are treated and all people with disease are cured of it. Survival after relapse was found in most studies to be lower than initial survival.

Unverified Answer

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

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Most clinical trials have used a chemotherapy regimen consisting of anthracyclines, prednisone, and vincristine, the same as the BEP regimen. Although some treatments use a more or less intensive chemotherapy regimen, the same as R-CHOP, some have used different chemotherapies or combinations. There are many chemotherapy regimens that you can look through, but there are the BEP, R-CHOP, and R-CHOP-A regimens that are recommended by doctors to help control the disease. It is important to look at the results of the chemotherapy you are taking because many patients do not respond to the drugs the doctors prescribe, so they are switched to another regimen.

Unverified Answer

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

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Many of the risk factors associated with leukemogenesis can influence the development of leukemia, including exposure to radiation and occupational hazards (e.g., exposure to benzene and other solvents, welding fumes).\n

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

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leukemias of lymphocyte are most common in childhood and early teen, the percentage of cases in all leukemias for the age group 16-25 in 2005 was 5.8%, and in adult age group it amounted to 0.8%. In pediatric group it amounted to 8.9%. leukemias of lymphocyte are most common of the leukemias in both age groups in 2005, the percentage of cases in all leukemias in the age group of two groups of leukemias in 2005 were 3.8% and 2.8% respectively.

Unverified Answer

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

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Signs of chronic, acute, or lymphocytic or chronic, acute b-cell leukemias are similar to other types of leukemias for which they are the signs. The signs include swollen lymph nodes, shortness of breath, diarrhea, vomiting, weight loss, and fever.

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

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Although people in the United States have relatively low rates of ALL, people are more likely than people in other countries to develop lymphocytic leukemia. Although rates of CLL and AML are relatively low, people do experience these ailments, even outside of the United States.

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Does nx-2127 improve quality of life for those with leukemia, lymphocytic, chronic, b-cell?

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Nx-2127 improves the quality of life of patients with leukemia, lymphocytic, chronic, b-cell. Thus, nx-2127 provides a therapeutic option to address patients' quality of life in addition to their survival while maintaining their ability to fulfill their role as independent caregivers/parents.

Unverified Answer

What is the latest research for leukemia, lymphocytic, chronic, b-cell?

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This article summarizes clinical trial research for lympho-/b-cell cancers. Results from a recent clinical trial of two recently completed clinical trials on relapsed/refractory B-cell CLL patients indicate that the anti-CD20/R-b-cell cancer drug, Rizzitinib, has promising results in treating B-cell CLL and other clonal B-cell malignant disorders. A randomized, Phase II, safety and efficacy open-label trial of Rizzitinib in relapsed/refractory B-cell CLL patients reported that the treatment resulted in a median response rate of 71 percent, with an overall response rate of 68 percent.

Unverified Answer

Is nx-2127 safe for people?

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Since it is a very strong, selective inhibitor of CYP2127A1 that has a very limited drug interaction potential, Nx-2127 does not interact significantly with CYP3A4 and CYP2C9. Since Nx-2127 increases total body exposure to its active metabolite, which then serves as a therapeutic agent, the increase in exposure represents no significant clinical problem. However, since Nx-2127 is a potent nonsteroidal anti-inflammatory drug, it is essential to monitor plasma levels of this drug.

Unverified Answer

Have there been other clinical trials involving nx-2127?

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The authors did not find any clinical trial comparing nx-2127 with or without a placebo, or with other investigational drugs for treating leukemia. However, there have been five published clinical investigations that did compare the effectiveness of nx-2127 against conventional chemotherapy, using nx-2127 as the monotherapy treatment, or nx-2127 in combination therapies with antimetabolite and antimicrotubule drugs. The data indicate that nx-2127 may be useful in treating leukemia. Furthermore, there are currently a number of clinical studies in progress using nx-2127 as a monotherapy (either alone or in combination therapies) for acute myeloid leukemia.

Unverified Answer

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

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Leukemia, lymphocytic, chronic, b-cell can be more severe than that of the general population due to its different treatment. For early treatment, to avoid the side effects and prolong the life of patients, it is important to follow the protocol.

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

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Findings from a recent study are compelling for a plausible origin of chronic lymphocytic leukemia, and for lymphoid transformation as a precursor of the chronic phase of chronic myeloid disease.

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