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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

Must not have

Substrates of CYP3A4/5 with a narrow therapeutic index

Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients with history of human immunodeficiency virus (HIV) disease are also excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I am not taking medications that are sensitive to changes by certain liver enzymes.

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I do not have active hepatitis B, hepatitis C, or HIV.

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I have had a heart attack in the last 6 months or have uncontrolled heart problems.

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I am currently pregnant or breastfeeding.

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I am not taking any strong medication that affects liver enzymes, nor consuming grapefruit or similar fruits.

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I have had a stem cell transplant or am on immunosuppressants due to this procedure within the last 6 months.

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I am willing to use effective birth control during the study.

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I am not currently on any experimental treatments or undergoing chemotherapy, radiotherapy, or immunotherapy.

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I am not taking strong medication that affects drug transport in the body.

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I am a woman who can have children and have not had a negative pregnancy test.

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My heart's pumping ability is significantly reduced.

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I have an infection that isn't getting better with antibiotics.

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My heart's electrical activity (QTcF) is normal and I don't have a family history of sudden death or long QT syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

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

Primary study objectives

Incidence of adverse events

Overall response rate

Secondary study objectives

Duration of response

Leukemia free survival

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

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

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

0 / 19Eligibility criteria met