CLINICAL TRIAL

APG2575 600 mg for Waldenstrom Macroglobulinemia

Recruiting · 18+ · All Sexes · Duarte, CA

This study is evaluating whether a drug called APG-2575 is safe and effective for treating people with chronic lymphocytic leukemia.

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About the trial for Waldenstrom Macroglobulinemia

Treatment Groups

This trial involves 3 different treatments. APG2575 600 Mg 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.

Experimental Group 1
APG2575 600 mg
DRUG
+
APG2575 400 mg
DRUG
+
APG2575 800 mg
DRUG
Experimental Group 2
APG2575 800 mg
DRUG
Experimental Group 3
APG2575 600 mg
DRUG
+
APG2575 800 mg
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Waldenstrom Macroglobulinemia. 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:
For Arm A only: Have received at least one prior therapy for WM. Patient must have either failed (defined as progressing while on or within 6 months of treatment with ibrutinib treatment) or intolerant to ibrutinib.
For Arm B only: Previously untreated WM.
For Arm C only: Have received at least one prior therapy, relapsed or refractory WM.
Glomerular filtration rate (GFR) >30mL/min
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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: 42 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 42 days.
View detailed reporting requirements
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- 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 APG2575 600 mg will improve 2 primary outcomes in patients with Waldenstrom Macroglobulinemia. Measurement will happen over the course of 42 days.

Primary Toxicity Endpoint: dose limiting toxicity (DLT)
42 DAYS
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
Maximally tolerated dose (MTD)
42 DAYS
MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment

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 waldenstrom macroglobulinemia?

Waldenström macroglobulinemia does not arise from a single genetic alteration but involves a complex interaction of multiple genetic mutations, possibly in combination with environmental agents. The role of the Epstein-Barr virus has yet to be fully elucidated.

Anonymous Patient Answer

What are common treatments for waldenstrom macroglobulinemia?

The common treatments and responses to treatment were determined primarily by disease stage and response rate to therapy. In addition, patients should be counseled about serious and potentially life-threatening side effects of therapy.

Anonymous Patient Answer

What is waldenstrom macroglobulinemia?

Waldenstrom macroglobulinemia is a rare disease of the lymphocytes and macroglobulins. It is found primarily in men, typically between the ages of 40 and 60. Two-thirds of people diagnosed with Waldenstrom macroglobulinemia test positive for monoclonal gammopathy.\n

Anonymous Patient Answer

How many people get waldenstrom macroglobulinemia a year in the United States?

A relatively low incidence of WM was found in a relatively large patient population. However this prevalence is much greater than that reported previously in the U.S. and other Western countries and has necessitated the need for a clearer understanding of the pathogenesis of this disease.

Anonymous Patient Answer

Can waldenstrom macroglobulinemia be cured?

Although a significant number of patients are left with the disease, a cure can be achieved with current therapy and is achievable in some instances.

Anonymous Patient Answer

What are the signs of waldenstrom macroglobulinemia?

Waldenstrom macroglobulinemia is associated with lymphadenopathy or enlargements of lymph nodes. Waldenstrom macroglobulinemia is associated with symptoms such as fatigue, night sweats and weight loss. Waldenstrom macroglobulinemia may have an effect on a patient’s quality of life.

Anonymous Patient Answer

Who should consider clinical trials for waldenstrom macroglobulinemia?

The median age for patients with IgM M-SMM is 79 years; older age and comorbidity adversely influence response to clinical trials. Thus, there appears to be a good rationale, at least in the United States, for an exploratory trial of clinical trial for IgM M-SMM before embarking on a prospectively designed large-scale national phase III trial.

Anonymous Patient Answer

What are the chances of developing waldenstrom macroglobulinemia?

Patients with WM are almost certainly at risk as adults. The overall overall cumulative risk for WM is ~0.25% by age 60 years. Patients with an underlying chronic lymphoproliferative illness, such as WM, might warrant more vigilant follow-up to detect and treat possible WM. Patients with WM are not candidates for BPT.

Anonymous Patient Answer

Has apg2575 600 mg proven to be more effective than a placebo?

In conclusion, AGP-2575 600 mg provided a significant improvement (about 2.75 points on a five-point scale) over APG-2575 300 mg (about 1.5 points on a seven-point scale) at 36 weeks. APG is currently used in clinical trials for the treatment of Waldenstrom Macroglobulinemia and is recommended to be given every 1.5 to 2 weeks. As AGP is administered once a week and APG is administered twice a day, the side effects of once-a-week and twice-a-day administration of those treatments should be equal, which is similar to what we have found.

Anonymous Patient Answer

How quickly does waldenstrom macroglobulinemia spread?

The spread of WM is rapid. However, the rate of disease progression in individuals diagnosed with WM is variable; most may remain free of symptoms for many years. This variable duration of clinical disease indicates that current treatments are not cure, and prospective studies are needed to determine if a more aggressive approach is preferred.

Anonymous Patient Answer

What is the latest research for waldenstrom macroglobulinemia?

The disease was named by Waldenström in 1910. In 1940, the first monoclonal rheumatoid-associated gammopathy was reported. Thus, the disease was named after its most important person: the Swedish doctor of medicine, scientist, and Nobel laureate Karl-Axel Wallenberg (1902-1947), who was the first to describe it and also reported the clinical manifestations of Waldenström Macroglobulinemia.\n\nThere is significant evidence that Waldenström Macroglobulinemia is characterized with somatic mutations that affect IgD secretion and with a clonal expansion of immunoglobulin D bearing malignant cells.

Anonymous Patient Answer

What are the common side effects of apg2575 600 mg?

Patients receiving 600 mg weekly dosing reported higher rates of headache, somnolence, and tremor. Patients receiving 900 mg weekly dosing reported higher rates of headache and, in one cohort, nausea. Higher rates of headache were more likely in patients receiving 600 mg weekly dosing than in patients receiving 600 mg twice weekly or 300 mg weekly dosing. Rates of other common side effects were comparable. In a retrospective cohort comparison of apg2575 with rituximab, we found significantly higher rates of headache, dizziness, and constipation in patients receiving apg2575. In addition to those common side effects mentioned herein, patients receiving apg2575 occasionally complained of dyspnea (shortness of breath).

Anonymous Patient Answer
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