What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include hypomethylating agents (HMAs) like azacitidine and decitabine, which can cause side effects such as cytopenias (low blood cell counts), infections, and gastrointestinal symptoms. Erythropoiesis-stimulating agents (ESAs) may increase the risk of thrombosis. Thrombopoietin mimetics, although sometimes used, carry a risk of leukemic transformation and bone marrow fibrosis. The investigational drug BMS-986253, studied in combination with DNMTi, may have similar side effects, including cytopenias and potential gastrointestinal issues, but specific side effects are still being evaluated.

What prior FDA approvals exist?

For the treatment of Myelodysplastic Syndrome (MDS), the FDA has approved hypomethylating agents such as azacitidine and decitabine. These agents are used to manage MDS by modifying the DNA methylation process, which can help control abnormal cell growth. Additionally, erythropoiesis-stimulating agents (ESAs) like epoetin alfa and darbepoetin alfa are approved to treat anemia associated with MDS. Thrombopoietin mimetics, such as romiplostim and eltrombopag, are considered for patients with severe thrombocytopenia, although their use is more cautious due to potential risks. These treatments are similar to the investigational drug BMS-986253, which is being studied in combination with DNA methyltransferase inhibitors (DNMTi) for MDS.

What other types of research exist?

Promising novel alternatives to BMS-986253 for Myelodysplastic Syndrome (MDS) patients include venetoclax in combination with hypomethylating agents (HMAs) such as azacitidine or decitabine. These combinations have shown efficacy in treating MDS and AML, particularly in patients with specific genetic mutations like IDH1/2. Another potential alternative is the use of novel oral HMAs that are currently in development and may offer similar benefits with more convenient administration.

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BMS-986253 for Myelodysplastic Syndrome

Phase 1 & 2

Waitlist Available

Led By Steven Z Pavletic, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have HR-MDS (R-IPSS >= 3.5) and received a minimum of 2 and maximum of 8 prior cycles for phase I and 4 for phase II of DNMTi therapy, or have LR-MDS (R-IPSS <3.5) and at least one cytopenia: granulocytes < 1.0 x 10^9/L and/or hemoglobin < 110 g/L with signs/symptoms of symptomatic anemia or transfusion-dependency, platelets < 100 x 10^9/L

ECOG performance status <=2 (Karnofsky >=60%)

Must not have

Active or uncontrolled autoimmune diseases

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986253 for adults with myelodysplastic syndromes (MDS), especially those who haven't responded to other treatments. The drug works by blocking a protein that helps cancer cells grow. Researchers hope this will slow down the disease and improve patients' immune responses.

Who is the study for?

Adults 18+ with Myelodysplastic Syndromes (MDS) who meet specific criteria, including having received certain prior treatments for MDS. They must have a life expectancy over 6 months and be able to perform daily activities with some degree of independence. Participants need proper liver and kidney function and cannot be pregnant or breastfeeding.

What is being tested?

The trial is testing BMS-986253 alone or combined with decitabine and cedazuridine in treating MDS. It's given in cycles, with infusions on specific days, alongside oral medication for some participants. The goal is to see if this new drug combination is safe and effective against MDS.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to the infusion process, impacts on organ functions due to the drugs' actions, as well as general symptoms like fatigue or issues from changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have MDS with specific blood counts and have had certain treatments.

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I can take care of myself but might not be able to do active work.

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My condition is officially diagnosed as MDS.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have active or uncontrolled autoimmune diseases.

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I do not have any unmanaged ongoing illnesses.

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I have low platelet counts that don't respond to transfusions or dangerously low white blood cell counts.

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I have had a stem cell transplant from a donor.

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I have chronic hepatitis B or C.

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I am HIV-positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)

Phase I: Optimal Biological Dose (OBD) for Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)

Phase I: Recommended Phase 2 Dose (RP2D) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)

+2 more

Secondary study objectives

Phase I: Area Under the Concentration Time Curve (AUC 0-24h) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes (MDS) With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)

Phase I: Concentration of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) at Steady State With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)

Phase I: Half-life of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)

+7 more

Other study objectives

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Phase I: Proportion of Participants With Dose-limiting Toxicities (DLT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) ParticipantsExperimental Treatment4 Interventions

Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.

Group II: Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) ParticipantsExperimental Treatment6 Interventions

Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.

Group III: Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) ParticipantsExperimental Treatment4 Interventions

Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.

Group IV: Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) ParticipantsExperimental Treatment6 Interventions

Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ECG

2016

Completed Phase 4

~33820

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 3

~230

BMS-986253

2020

Completed Phase 2

~50

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Myelodysplastic Syndrome (MDS) include DNA methyltransferase inhibitors (DNMTis) like azacitidine and decitabine, which inhibit DNA methylation to reactivate tumor suppressor genes and induce apoptosis in malignant cells. This mechanism is crucial for controlling disease progression and improving blood cell counts in MDS patients. Erythropoiesis-stimulating agents (ESAs) are also used to boost red blood cell production and alleviate anemia. The investigational drug BMS-986253, studied in combination with DNMTis, aims to enhance these therapeutic effects, potentially offering a more effective treatment for MDS.

Lenalidomide as a disease-modifying agent in patients with del(5q) myelodysplastic syndromes: linking mechanism of action to clinical outcomes.Combination therapy with DNA methyltransferase inhibitors in hematologic malignancies.