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CAR T-cell Therapy

Siremadlin for Acute Myeloid Leukemia

Duarte, CA

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 1 year and 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.

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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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- AML in first CR (CR1) prior to allo-SCT with one of the following:

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-- Therapy-related AML (t-AML).

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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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- AML in second or greater CR (≥CR2) prior to allo-SCT.

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- Unmanipulated/T cell-replete bone marrow or peripheral blood stem cells as a graft source.

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- Matched related (family) donor (MFD) or matched unrelated donor (MUD): Human Leukocyte Antigen (HLA) matching of donor and recipient should be at a minimum of 8/8 antigen or allele matched at HLA-A, -B, -C, -DRB1 loci.

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- Post-allo-SCT, participants must have achieved CR or CRi with no current evidence of hematologic relapse

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- Eastern Cooperative Oncology Group (ECOG ) performance status 0, 1 or 2.

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- Laboratory test results indicating adequate liver and kidney function laboratory test results

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Prior exposure to MDM-inhibitor

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You currently have a type of graft-vs-host disease called acute or chronic GvHD that requires treatment.

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Recipient of allo-SCT from MUD with ≥1 antigen or allele mismatch at HLA-A, -B, -C, -DRB1 locus (HLA matching < 8/8 antigens)

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You had a stem cell or cord blood transplant with a donor who is not a full match with you.

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Prior systemic AML-directed treatments given at any time after allo-SCT (including DLI)

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You have digestive problems like severe diarrhea, uncontrollable nausea or vomiting, or GI bleeding that may prevent you from taking and absorbing oral siremadlin.

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Any concurrent severe and/or active uncontrolled bacterial, viral or fungal infection requiring parenteral antibacterial, antiviral or antifungal therapy. Prophylactic antimicrobial use (oral or parenteral) is allowed.

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You cannot take medication that increases the activity of a certain enzyme (CYP3A) 14 days before or during the study.

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You have a significant heart condition or abnormal heart rhythm.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year and 2 years after start of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year and 2 years after start of study treatment

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 (Part 2)

Rate of Dose Limiting Toxicities (DLTs) With Siremadlin Monotherapy in Part 1 (Dose Confirmation With Siremadlin Monotherapy)

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 at 1 Year and 2 Years After Start of Study Treatment

Incidence of Graft Versus Host Disease (GvHD)

PK Characteristic Cmax of Siremadlin

+8 more

Awards & 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) received siremadlin monotherapy in part 1 and were to have received 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

0 / 18Eligibility criteria met