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Siremadlin for Acute Myeloid Leukemia
Study Summary
This trial tests a new drug to prevent leukemia relapse in adult patients after stem cell transplant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You had a stem cell or cord blood transplant with a donor who is not a full match with you.You had a severe case of GvHD in the past or have ongoing moderate to severe GvHD. If you had a milder form of GvHD in the past, it must have fully resolved for at least 4 weeks before starting the study treatment.You cannot have received any cancer treatments, including experimental ones, within a certain period of time before starting the study.You cannot take medication that increases the activity of a certain enzyme (CYP3A) 14 days before or during the study.You have a significant heart condition or abnormal heart rhythm.If you have received a specific type of stem cell transplant (called an allo-SCT), it must meet certain requirements:Participants must have a high chance of their disease coming back after a stem cell transplant.You need to have lymphocytes from a donor that can be frozen and used later or obtained easily, if needed for the trial. This only applies to part 2 of the trial.You have a specific type of leukemia that developed as a result of a previous bone marrow disorder or blood cancer.You currently have a type of graft-vs-host disease called acute or chronic GvHD that requires treatment.You have digestive problems like severe diarrhea, uncontrollable nausea or vomiting, or GI bleeding that may prevent you from taking and absorbing oral siremadlin.
- Group 1: Siremadlin (HDM201)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What are the available venues for this experiment?
"This trial is presently recruiting from 10 sites, including Freiburg, Valencia and Cardiff. To minimize travel requirements if you choose to participate, selecting the clinic closest to your location is ideal."
Are individuals being accepted for enrollment in this research study?
"According to the data presented on clinicaltrials.gov, this medical experiment is actively recruiting participants as of April 6th 2023. The trial was first published 23rd February 2023."
How many people are partaking in this research endeavor?
"Affirmative. According to the records on clinicaltrials.gov, this research project is actively seeking candidates and was initially posted on February 23rd 2023 with a most recent update taking place April 6th of the same year. 38 people need to be recruited from 10 distinct medical institutions in order for it to reach completion."
What are the projected outcomes of this experiment?
"The main observation in this trial, measured over a 4-week period, is the onset of dose limiting toxicity (DLT) when siremadlin and donor lymphocyte infusion are combined. Secondary goals include permanent study treatment discontinuation rate due to GvHD or other adverse events; peak plasma concentration of siremadlin; and time from start of study treatment until first documented hematologic relapse or death."
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