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Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

(PyramIDH)

Sponsored by Institut de Recherches Internationales Servier

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 11, 2026

Phase

Clinical Trial

Sponsor

Institut de Recherches Internationales Servier

Enrollment Target

48

Start Date

Dec 2024

๐Ÿ“Š
1 of 48 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle.

Who Can Participate

Inclusion Criteria

Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):
Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.
Low and moderate low-risk MDS per IPSS-M score must:
Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND
Have a blast count between 5-19% AND
Be eligible for HMA therapy (very low risk participants are to be excluded)
Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation

Exclusion Criteria

Received prior anticancer/disease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

48 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Institut de Recherches Internationales Servier

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Denver

Colorado

Location available
View Denver location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
NOT_YET_RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Chapel Hill

North Carolina

Location available
View Chapel Hill location page
RECRUITING

Columbus

Ohio

Location available
View Columbus location page
RECRUITING

Eugene

Oregon

Location available
View Eugene location page
NOT_YET_RECRUITING

Dallas

Texas

Location available
View Dallas location page
RECRUITING

Houston

Texas

Location available
View Houston location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Find More Myelodysplastic Syndromes Trials by City

Browse all myelodysplastic syndromes clinical trials in these cities โ€” not just this study.

Looking for Myelodysplastic Syndromes Treatment in Denver?

Join others in Colorado exploring innovative treatment options through clinical research

Myelodysplastic Syndromes Treatment Options in Denver, Colorado

If you're searching for Myelodysplastic Syndromes treatment in Denver, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Denver, Chicago, Boston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Myelodysplastic Syndromes. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Colorado
Now Enrolling
Up to 48 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Myelodysplastic Syndromes?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Myelodysplastic Syndromes

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Myelodysplastic Syndromes Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06465953. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.