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CAR T-cell Therapy
Siremadlin for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- AML in first CR (CR1) prior to allo-SCT with one of the following:
-- Therapy-related AML (t-AML).
Must not have
Prior exposure to MDM-inhibitor
Active acute GvHD (aGvHD) of any grade (per Harris et al 2016) and/or active chronic GvHD (cGvHD ) of any grade (per NIH criteria (Jagasia et al 2015)) requiring systemic therapy at time of study treatment initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year and at 2 years after start of study treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug to prevent leukemia relapse in adult patients after stem cell transplant.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) who are in remission after a stem cell transplant but at high risk of relapse. They should be within 60-120 days post-transplant, have had certain genetic risks or therapy-related AML, and show no signs of hematologic relapse. Participants need good organ function and an adequate blood count.
What is being tested?
The study tests the safety and effectiveness of Siremadlin alone, and combined with donor lymphocyte infusion (DLI), in preventing AML relapse after transplantation. It aims to find the right dose and schedule for patients who've received transplants from matched donors.
What are the potential side effects?
While specific side effects for Siremadlin aren't listed here, common ones may include gastrointestinal issues like nausea or diarrhea, potential liver or kidney problems indicated by lab tests, as well as possible immune system reactions due to DLI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a specific type of leukemia that developed as a result of a previous bone marrow disorder or blood cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You currently have a type of graft-vs-host disease called acute or chronic GvHD that requires treatment.
Select...
You had a stem cell or cord blood transplant with a donor who is not a full match with you.
Select...
You have digestive problems like severe diarrhea, uncontrollable nausea or vomiting, or GI bleeding that may prevent you from taking and absorbing oral siremadlin.
Select...
You cannot take medication that increases the activity of a certain enzyme (CYP3A) 14 days before or during the study.
Select...
You have a significant heart condition or abnormal heart rhythm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year and at 2 years after start of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year and at 2 years after start of study treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mutagenicity Tests
Percentage of participants who are alive and maintained complete remission (CR) or complete response with incomplete hematological recovery (CRi) with no evidence of hematologic relapse
Time to Dose Limiting Toxicity (DLT) with siremadlin in combination with Donor Lymphocyte Infusion (DLI), in part 2
Secondary study objectives
Cumulative incidence of AML relapse
Incidence of Graft versus Host Disease (GvHD)
PK characteristic Cmax of siremadlin
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Siremadlin (HDM201)Experimental Treatment1 Intervention
Participants with AML post allogeneic stem cell transplantation (allo-SCT) will receive siremadlin monotherapy in part 1 and siremadlin monotherapy as well as in combination with donor lymphocyte infusion in part 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siremadlin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,294 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Siremadlin (HDM201)
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.