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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
Participants with AML diagnosis, who underwent one allo-SCT to treat AML and are currently at ≥ Day 60 but no later than Day 120 (≤ Day 120) post allo-SCT.
- AML in first CR (CR1) prior to allo-SCT with one of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year and at 2 years after start of study treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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You have a specific type of leukemia that developed as a result of a previous bone marrow disorder or blood cancer.
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If you have received a specific type of stem cell transplant (called an allo-SCT), it must meet certain requirements:
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year and at 2 years after start of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year and at 2 years after start of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Cumulative incidence of AML relapse
Incidence of Graft versus Host Disease (GvHD)
PK characteristic Cmax of siremadlin
+8 more

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
2,851 Previous Clinical Trials
4,197,581 Total Patients Enrolled

Media Library

Siremadlin (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05447663 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Siremadlin (HDM201)
Acute Myeloid Leukemia Clinical Trial 2023: Siremadlin Highlights & Side Effects. Trial Name: NCT05447663 — Phase 1 & 2
Siremadlin (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05447663 — Phase 1 & 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~4 spots leftby Mar 2025