Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo therapy for rare blood cancers put on hold

NCT ID NCT06661915

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 7 times

Summary

This phase 2 trial compares a drug combo (ASTX727 plus iadademstat) against ASTX727 alone for people with advanced myeloproliferative neoplasms (MPNs), a group of rare blood cancers. The study aims to see if adding iadademstat improves complete response rates. However, the trial is currently suspended, and only 62 participants were planned.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ASTX727 (decitabine and cedazuridine) with or without iadademstat
What this could lead to
If successful, this could point toward a more effective treatment for advanced myeloproliferative neoplasms, potentially improving response rates.
What could go wrong
This is an early-phase trial with only 62 participants, currently suspended. The combination may not prove more effective than ASTX727 alone, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have morphologically confirmed diagnosis of Philadelphia-chromosome negative MPN in accelerated-phase (10-19% myeloid blasts) or blast-phase (≥ 20% myeloid blasts) arising from polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, or MPN not otherwise specified, as per the World Health Organization (WHO) 2016 classification OR myelodysplastic syndrome (MDS)/MPN overlap syndromes (e.g., chronic myelomonocytic leukemia \[CMML\]) with ≥ 10% blasts * Patients must not have received prior DNMTi. Previous use of janus kinase (JAK) inhibition, hydroxyurea, and interferon is allowed. There is no required washout period for JAK inhibition and interferon * Age ≥ 18 years * Because no dosing or adverse event data are currently available on the use of ASTX727 (35 mg decitabine + 100 mg cedazuridine) in combination with iadademstat in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome, thought to be related to MPN-AP/BP, or due to extrasvascular hemolysis. In these cases conjugated bilirubin should be ≤ 2.0 x ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN * Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 by Modification of Diet in Renal Disease (MDRD) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better * The effects of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat on the developing human fetus are unknown. For this reason and because DNMT inhibitor and LSD1 inhibitor agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 6 months after completion of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and 6 months after completion of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat administration * Women of child-bearing potential must agree not to donate or freeze egg(s) during the course of this study or within 180 days after receiving their last dose of study drug. Male patients must agree not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants * Patient is able to swallow oral medications * Patients must have a body weight of at least 50 kg due to the use of flat doses. If a patient is on continued treatment and is receiving benefit, but falls below 50 kg, they may stay on the study per investigator discretion. Otherwise, they will have to come off the study * Peripheral white blood cell (WBC) count \< 25 x 10\^9/L on day 1 prior to treatment initiation. Hydroxyurea is allowed for cytoreduction until 24 hours prior to study treatment. Hydroxyurea may be resumed during cycle 1 if WBC count rises above 25 x 10\^9/L. Use of hydroxyurea beyond cycle 1 should be discussed with study chair Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia * Patients who are receiving any other investigational agents or had received any investigational products within 3 weeks or 5 half-lives (whichever is shorter) prior to first dose of study treatment * Patients with a Fridericia's corrected QT interval (QTcF) \> 450 ms * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 (35 mg decitabine + 100 mg cedazuridine) or iadademstat * Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: tranylcypromine or phenelzine * Patients with IDH1-mutated MPN blast phase (≥ 20% blasts). Patients with an IDH1-mutation with MPN-AP (10-19%) blasts are eligible for this study * Iadademstat concomitant medication considerations: Patients are not allowed to receive prophylactic hematopoietic colony stimulating factors, any complementary or alternative medicine \[any of various systems of healing or treating disease (as non-prescription supplements, herbal medicine and homeopathy)\]. Of note, patients may receive granulocyte colony-stimulating factor for management of febrile neutropenia or for prolonged neutropenia * Patients may not receive administration of live or live-attenuated vaccines. Administration of non-live vaccines included ribonucleic acid (RNA)-based vaccines is allowed and is recommended for pneumococcal, coronavirus, and influenza vaccines * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous * Pregnant women are excluded from this study because iadademstat is an LSD1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iadademstat, breastfeeding should be discontinued if the mother is treated with iadademstat. These potential risks also apply to the ASTX727 (35 mg decitabine + 100 mg cedazuridine) used in this study * Patients who require treatment while on study with concomitant drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline) except for drugs that are considered absolutely essential for the care of the patient and with appropriate treatment monitoring

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Accelerated phase myeloproliferative neoplasm are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acquired polycythemia vera atypical chronic myeloid leukemia, BCR-ABL1 negative blast phase chronic myelogenous leukemia, BCR-ABL1 positive essential thrombocythemia leukemia, myeloid, accelerated-phase myelodysplastic/myeloproliferative disease myelodysplastic/myeloproliferative neoplasm myelofibrosis Myeloproliferative Disorders myeloproliferative neoplasm myeloproliferative neoplasm, unclassifiable primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Accelerated phase myeloproliferative neoplasm Blast phase myeloproliferative neoplasm Essential thrombocythemia Myelodysplastic/myeloproliferative neoplasm Myeloproliferative neoplasm, not otherwise specified Polycythemia vera Primary myelofibrosis Secondary myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Cabarrus/LCI-Concord

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • NYP/Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Stanford Cancer Institute Palo Alto

    RECRUITING

    Palo Alto, California, 94304, United States

    Contact Email: •••••@•••••

  • UC Comprehensive Cancer Center at Silver Cross

    RECRUITING

    New Lenox, Illinois, 60451, United States

    Contact Email: •••••@•••••

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • UChicago Medicine Northwest Indiana

    RECRUITING

    Crown Point, Indiana, 46307, United States

    Contact Email: •••••@•••••

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Doral

    RECRUITING

    Doral, Florida, 33166, United States

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    RECRUITING

    Hollywood, Florida, 33021, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    RECRUITING

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Chicago Medicine-Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

    Contact Email: •••••@•••••

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Clinical Research Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • University of Kansas Hospital-Indian Creek Campus

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    RECRUITING

    North Miami, Florida, 33181, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.