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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
≥18 years of age
Female subjects who are of non-reproductive potential or using highly effective methods of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
No Placebo-Only Group

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 below
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I am 18 years old or older.
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I am either not able to have children or I am using effective birth control.
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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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My liver and kidney functions are within the required range.
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My diagnosis of Waldenstrom's macroglobulinemia (WM) is confirmed.
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I have Waldenstrom macroglobulinemia needing treatment according to specific guidelines.

MAPLE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
45 Previous Clinical Trials
3,827 Total Patients Enrolled

Media Library

APG2575 (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT04260217 — Phase 1
Waldenstrom Macroglobulinemia Research Study Groups: APG2575 400 mg, APG2575 600 mg, APG2575 800 mg arm
Waldenstrom Macroglobulinemia Clinical Trial 2023: APG2575 Highlights & Side Effects. Trial Name: NCT04260217 — Phase 1
APG2575 (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04260217 — Phase 1

Frequently Asked Questions

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

Are there opportunities for new enrollees in the trial?

"Affirmative. Clinicaltrials.gov has the latest information indicating that this clinical trial is proactively looking for participants and was initially entered into the database on May 30th 2021. The study requires 123 patients to be recruited from 6 separate medical centres."

Answered by AI

How many clinical sites are participating in this trial?

"As of now, 6 clinical sites are running this trial in locations such as Duarte, Jacksonville and Los Angeles. To minimise the hassle associated with travel, it is wise to select the closest clinic when signing up for participation."

Answered by AI

Is it possible to join the clinical trial I'm inquiring about?

"This entire medical trial is looking to enroll 123 individuals aged 18-95 that have been diagnosed with Waldenstrom Macroglobulinemia. To qualify, some of these patients must possess a Glomerular Filtration Rate higher than 30mL/min and meet the following criteria: Arm A requires at least one prior therapy for WM as well as failure or intolerance to ibrutinib treatment; Arm B needs previously untreated WM patients; Arm C seeks those who have received at least one prior therapy and relapsed or refractory WM."

Answered by AI

What is the total sample size of this clinical research?

"The project sponsor, Ascentage Pharma Group Inc., must acquire 123 participants who meet the criteria to undertake this trial. The study is based in City of Hope (Duarte, California) and Mayo Clinic (Jacksonville, Florida)."

Answered by AI

Does this medical research accept participants above the age of thirty?

"This research initiative has specified age restrictions for potential participants- those below the age of 18 and above 95 are excluded. Conversely, individuals from these two cohorts can participate in 8 and 79 studies respectively."

Answered by AI

Is APG2575 400 mg a hazard-free dosage for human consumption?

"Due to the scarcity of clinical data on APG2575 400 mg, we can only rate its safety at 1. This is a Phase 1 trial which requires further evidence for both efficacy and safety."

Answered by AI
~29 spots leftby Dec 2024