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Anti-cancer agent
APG-2575 Combination Therapy for Waldenström Macroglobulinemia (MAPLE-1 Trial)
Phase 1
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
WM patients with symptomatic and measurable disease requiring treatment as per mSMART guidelines (Kyle 2003)
Local confirmed clinicopathological diagnosis of WM in accordance with the consensus panel of the Second International Workshop on WM (Owen 2003)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
MAPLE-1 Trial Summary
This trial is testing a new drug, APG-2575, to see if it is safe and effective when used alone or with other drugs.
Who is the study for?
Adults over 18 with Waldenström Macroglobulinemia who need treatment can join. They must have a life expectancy of at least 3 months, good liver and kidney function, and be generally healthy (ECOG ≤1). Women should use birth control if they can have children. People can't join if they've had certain treatments for WM or other health issues like recent surgery, active infections, heart disease, or bleeding disorders.Check my eligibility
What is being tested?
The trial is testing APG-2575 alone or combined with Ibrutinib or Rituximab to see how safe and effective it is for treating Waldenström Macroglobulinemia. It's also looking at how the body processes the drug. Participants will receive different doses of APG-2575 to find out which one works best.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, digestive problems, fatigue, liver issues reflected in blood tests results, potential bleeding complications due to interaction with blood thinners like warfarin and risks associated with heart conditions.
MAPLE-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Waldenstrom macroglobulinemia needing treatment according to specific guidelines.
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My diagnosis of Waldenstrom's macroglobulinemia (WM) is confirmed.
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My liver and kidney functions are within the required range.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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My condition requires treatment according to specific medical guidelines.
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My blood counts meet the required levels for treatment.
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I am either not able to have children or I am using effective birth control.
MAPLE-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally tolerated dose (MTD)
Primary Toxicity Endpoint: dose limiting toxicity (DLT)
MAPLE-1 Trial Design
3Treatment groups
Experimental Treatment
Group I: APG2575 800 mg armExperimental Treatment1 Intervention
APG2575 800 mg arm ramp up
Group II: APG2575 600 mgExperimental Treatment2 Interventions
APG2575 600 mg ramp up arm
Group III: APG2575 400 mgExperimental Treatment3 Interventions
APG2575 400mg ramp up arm
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Who is running the clinical trial?
Ascentage Pharma Group Inc.Lead Sponsor
49 Previous Clinical Trials
5,019 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a stroke or brain bleed in the last year.I have Waldenstrom macroglobulinemia needing treatment according to specific guidelines.My condition did not improve after my last treatment with a medicine called rituximab.I still have side effects from my previous WM treatment.My diagnosis of Waldenstrom's macroglobulinemia (WM) is confirmed.I do not have any ongoing infections that aren’t being treated.My liver and kidney functions are within the required range.I am 18 years old or older.I am fully active and can carry on all pre-disease activities without restriction.I have not had major surgery in the last 14 days.My condition requires treatment according to specific medical guidelines.My blood counts meet the required levels for treatment.I do not have brain involvement, active infections, or serious unresolved health issues.I have had an active or chronic hepatitis B or C infection.You have had a severe allergic reaction to mouse proteins or any part of rituximab.I am either not able to have children or I am using effective birth control.I have not undergone plasmapheresis within the last 35 days.I cannot swallow pills or have a condition that affects how my body absorbs nutrients.I have a serious heart condition that is currently affecting me.I have another type of cancer at the same time.You are expected to live for at least 3 more months.You have important abnormal findings on your heart's ECG test.I have never been treated with ibrutinib.I have received treatment for Waldenstrom's macroglobulinemia.I need treatment with a strong medication that affects liver enzymes.I have been treated with ibrutinib or another BTK inhibitor before.I finished treatment for an infection less than 14 days ago.I am currently taking warfarin or similar blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: APG2575 400 mg
- Group 2: APG2575 600 mg
- Group 3: APG2575 800 mg arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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