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New treatment option for Myelodysplastic Syndromes
Official title Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT06502145
What this study is testing
What is Azacitidine Level -1?
Azacitidine Level -1 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelodysplastic syndromes.
Also referred to as Vidaza, Onureg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I study with a primary objective of determining the recommended phase II dose of iadademstat with azacitidine in adult subjects with myelodysplastic syndrome (MDS).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female 18 years or older.
- Patients must have a diagnosis of myelodysplastic syndrome (MDS), or MDS / myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML)...
- Intermediate, high, or very-high risk by the Revised International Prognostic Scoring System (IPSS-R).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (0-3 if performance status is considered due to MDS).
- Patient must have a body weight of at least 50 kg.
You likely can't join if
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study:
- Prior therapy with hypomethylating agent or Lysine-specific histone demethylase 1A (LSD1) inhibitor. If patients were treated with any other agents...
- Patient will require treatment while on study with concomitant drugs that target the 5- hydroxytryptamine2B (5-HT2B) receptor or the sigma...
- Treatment with systemic antineoplastic chemotherapy within 14 days or 5 half-lives from the last dose - whichever is sooner - before Cycle 1, Day 1...
- Patient is on treatment with any investigational products within 3 weeks prior to the first dose of study treatment.
- Patient has had major surgery within 4 weeks prior to the first study dose.
See the full eligibility criteria
Who can join
- Male or female 18 years or older.
- Patients must have a diagnosis of myelodysplastic syndrome (MDS), or MDS / myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML) as defined by the World Health Organization (WHO) criteria.
- Intermediate, high, or very-high risk by the Revised International Prognostic Scoring System (IPSS-R).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (0-3 if performance status is considered due to MDS).
- Patient must have a body weight of at least 50 kg.
- Patient must meet the following screening clinical laboratory values as specified below: a. Hematologic: white blood cell (count) (WBC) below 30 x 109/L. Hydroxyurea can be used to achieve this level b. Hepatic: i...
- Patient is able to swallow oral medications.
- Female people who:
- Are postmenopausal for at least one year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential: i. Agree to practice one highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent...
- Male people, even if surgically sterilized (i.e., status post vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through six months after the last dose of study drug (female and male...
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female...
- Agree to not to donate or freeze sperm during the course of this study or within 180 days after receiving their last dose of study drug.
- Ability to provide informed consent or have a legally authorized representative provide consent.
What rules you out
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study:
- Prior therapy with hypomethylating agent or Lysine-specific histone demethylase 1A (LSD1) inhibitor. If patients were treated with any other agents having KDM1A/LSD1 inhibitory activity (such as tranylcypromine or...
- Patient will require treatment while on study with concomitant drugs that target the 5- hydroxytryptamine2B (5-HT2B) receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline) except for...
- Treatment with systemic antineoplastic chemotherapy within 14 days or 5 half-lives from the last dose - whichever is sooner - before Cycle 1, Day 1 of therapy. Radiation within 14 days before Cycle 1, Day 1 of therapy...
- Patient is on treatment with any investigational products within 3 weeks prior to the first dose of study treatment.
- Patient has had major surgery within 4 weeks prior to the first study dose.
- Patients with uncontrolled hypertension (i.e., systolic blood pressure \>180 mm Hg, diastolic blood pressure \>95 mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle 1, Day 1 is allowed.
- Patients with known poorly controlled diabetes (glycosylated hemoglobin (HbA1c) ≥8%) unless actively managed with appropriate therapy; patients with a history of transient glucose intolerance due to corticosteroid...
- Patient has known active congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patients with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram...
- Patients with known long QT Syndrome at screening.
- History of allogeneic stem cell transplantation or CAR-T therapy within past 60 days.
- Patient has evidence of active uncontrolled viral, bacterial, or systemic fungal infection (i.e., no signs of severe systemic inflammatory response that makes patient clinically unstable in the opinion of the...
- Manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease that may alter the absorption of iadademstat.
- Pregnant or lactating / breastfeeding women.
- Patient has any condition which, in the investigator's opinion, makes the patient unsuitable for study participation. For example, any inter-current illness or social situation that will limit compliance with study...
- Patient presents a known contraindication to any of the treatment drug excipients.
- Patient has known active hepatic disorder or is known to be positive for hepatitis B or C infection with the exception of those with undetectable viral load within 3 months (Hepatitis B or C testing is not required for...
- Patient is known to have human immunodeficiency virus infection. (HIV testing is not required for eligibility assessment).
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.