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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 below

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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

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)

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor

48 Previous Clinical Trials

4,727 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

Recent research and studies

clinicaltrials.govStudy

APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia

2021. "APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260217.

All > Waldenstrom Macroglobulinemia