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DNA Methyltransferase Inhibitor

Seclidemstat + Azacitidine for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

Phase 1 & 2
Recruiting
Led By Guillermo M Bravo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years as myelodysplastic syndrome (MDS) is a very rare disease in the pediatric setting
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 50 ml/min for patients with creatinine levels > 1.5 x ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing the combination of seclidemstat and azacitidine to treat patients with myelodysplastic syndrome or chronic myelomonocytic leukemia.

Who is the study for?
Adults diagnosed with myelodysplastic syndrome or chronic myelomonocytic leukemia, who haven't responded to certain treatments like azacitidine, can join this trial. They must understand the study and agree to participate, have proper kidney and liver function, an ECOG performance status of 0-2, and not be pregnant or breastfeeding. Those with uncontrolled infections, heart issues, or taking specific drugs that affect the trial medications are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of seclidemstat and azacitidine to determine the best dose for treating certain blood cancers. Seclidemstat blocks enzymes needed for cancer cell growth while azacitidine may prevent cancerous growths from forming. The goal is to see if this combo kills more cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions related to enzyme inhibition which could affect cell growth in general leading to fatigue, digestive issues or blood disorders. Azacitidine might cause nausea, vomiting or injection site reactions. Organ inflammation and increased risk of infection are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney function is within the normal range or slightly above.
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I have been diagnosed with MDS or CMML.
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I am able to get out of my bed or chair and move around.
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My condition did not improve after 6 treatments with specific drugs or it got worse after any number of treatments.
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My condition is a type of blood cancer with a certain level of risk or specific genetic changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Overall response rate
Secondary outcome measures
Duration of response
Leukemia free survival
Overall survival
+1 more

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT03047993
14%
Infection
11%
Febrile neutropenia
11%
Platelet count decreased
11%
Upper respiratory infection
7%
Death
7%
Anemia
7%
Cardiac Disorders, Other - Decompensated Heart Failure
7%
Intracranial hemorrhage
7%
Lung infection
7%
Neoplasms benign, malignant and unspecified
4%
Blood and lymphatic disorders - Other, specify
4%
Gastrointestinal Disorders, Other-Melena
4%
General disorders and administration site conditions-Other, Neck Swelling
4%
Immune System Disorders, Other
4%
Scrotal infection
4%
Urinary tract infection
4%
White blood cell decreased
4%
Confusion
4%
Acute Kidney Injury
4%
Fever
4%
Cholecystitis
4%
Dyspnea
4%
Epistaxis
4%
Fatigue
4%
Fracture
4%
Gastrointestinal Disorders-Hemorrhage
4%
Hematoma
4%
Hypotension
4%
Hypoxia
4%
Mucositis
4%
Non-cardiac chest pain
4%
Respiratory failure
4%
Soft tissue Infection
4%
Stroke
4%
Thromboembolic Event
4%
Vascular Disorders, Other-Hematoma
4%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Glutaminase Inhibitor CB-839, Azacitidine)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, seclidemstat)Experimental Treatment2 Interventions
Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7. Patients also receive seclidemstat PO QD on day 1 of cycle 1 and PO BID on days 2-28 of cycle 1 and on days 1-28 of all subsequent cycles. There are 6 planned dose levels for seclidemstat: 300 mg, 450 mg, 600 mg, 900 mg, 1200 mg and 1500 mg. Successive cohorts of eligible patients will be treated with azacitidine. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,981 Previous Clinical Trials
1,789,687 Total Patients Enrolled
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
180 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04734990 — Phase 1 & 2
Myelodysplastic Syndrome Research Study Groups: Treatment (azacitidine, seclidemstat)
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04734990 — Phase 1 & 2
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04734990 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there previous studies that suggest Seclidemstat is effective?

"As of right now, there are 179 clinical trials underway that are researching Seclidemstat. Out of those179 trials, 33 of them are in Phase 3. Even though a large majority of the studies for Seclidemstat originate from Saint Louis, Missouri, there are 5711 total locations running trials for Seclidemstat."

Answered by AI

Are patients currently being signed up for this experimental treatment program?

"That is correct, the listing on clinicaltrials.gov shows that this study requires 44 more patients and is currently open for enrollment at 1 site. The trial was first posted on 7/7/2021 and has been updated 9/21/2022."

Answered by AI

How many individuals are currently enrolled in this program?

"That is correct. The clinicaltrials.gov website has the latest information on this trial, which was posted on July 7th, 2021 and updated September 21st, 2022. The study is looking for 44 patients from 1 site."

Answered by AI

What condition does Seclidemstat help alleviate?

"Seclidemstat is an effective treatment for malignant neoplasms, 20-30% blasts, and neutropenia and/or thrombocytopenia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
2021. "Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04734990.
~13 spots leftby Sep 2025
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