← Back to Search

Anti-metabolites

Iadademstat + Venetoclax + Azacitidine for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Natalie Galanina

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Patients must have established and confirmed diagnosis of AML according to the European LeukemiaNet 2022 classification criteria

* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of iadademstat in combination with venetoclax and azacitidine in patients \< 18 years of age, children are excluded from this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study enrollment to disease progression, treatment failure (failure to achieve cr or <5% bone marrow blasts) confirmed relapse or death, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and best dosage of iadademstat in combination with azacitidine and venetoclax for patients with acute myeloid leukemia (AML) who have not

Who is the study for?

This trial is for adults over 18 with newly diagnosed Acute Myeloid Leukemia (AML) who haven't started treatment, except possibly hydroxyurea. They should have a white blood cell count below a certain level, be able to swallow pills, weigh at least 50 kg, and have normal liver and kidney function tests.

What is being tested?

The trial is testing the safety and optimal dosage of Iadademstat combined with Azacitidine and Venetoclax in treating AML. These drugs work differently to stop cancer cells from growing by killing them or blocking proteins they need to survive.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response to the drugs, issues affecting blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, liver function changes, and potential kidney-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My leukemia diagnosis matches the 2022 European standards.

Select...

I am 18 years old or older.

Select...

My body weight is at least 50 kg.

Select...

I can do most activities, but may need help.

Select...

My kidney function is moderately reduced or better.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study enrollment to disease progression, treatment failure (failure to achieve cr or <5% bone marrow blasts) confirmed relapse or death, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study enrollment to disease progression, treatment failure (failure to achieve cr or <5% bone marrow blasts) confirmed relapse or death, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment to disease progression, treatment failure (failure to achieve cr or <5% bone marrow blasts) confirmed relapse or death, up to 4 years 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 (AEs)

Incidence of dose limiting toxicity (DLT)

Secondary study objectives

Duration of response

Event free survival

Minimal residual disease (MRD)-negative composite complete remission (cCR)

+3 more

Other study objectives

MRD-negative cCR and molecular/cytogenetic risk group status

Percentage LSD1 target engagement by chemoprobe in peripheral blood mononuclear cells

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 (iadademstat, venetoclax, azacitidine)Experimental Treatment6 Interventions

INDUCTION: Patients receive iadademstat PO QD on days 1-5, 8-12, and may also receive it on days 15-19, venetoclax PO QD on days 1-14 or 1-21 and azacitidine IV over 10-40 minutes or SC on days 1-7 or 1-5 and 8-9 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo buccal swab collection on study. CONSOLIDATION: Patients receive iadademstat PO QD on days 1-5, 8-12 and may also receive it on days 15-19, venetoclax PO QD on days 1-7 or 1-14 and azacitidine IV over 10-40 minutes or SC on days 1-7 or 1-5 and 8-9 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buccal Swab

2006

N/A

~1890

Biospecimen Collection

2004

Completed Phase 3

~2020