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Anti-metabolites

M3814 + Chemotherapy for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Brian A Jonas

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

- Refractory: no CR or CRi after one or more cycles of induction. Induction cycles include regimens with the intent to achieve remission and can include high intensity and/or low intensity regimens

Patients must be medically eligible to receive MEC, including acceptable pre-study cardiac function (left ventricular ejection fraction of >= 45%) and lifetime anthracycline exposure (=< 360 mg/m^2 daunorubicin equivalents)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a drug called M3814 in combination with mitoxantrone, etoposide, and cytarabine to see if it can treat acute myeloid leukemia that has come back or does not respond to treatment.

Who is the study for?

Adults (18+) with acute myeloid leukemia that's relapsed or hasn't responded to treatment, without severe allergies or conditions. They must have acceptable organ function and performance status, no active central nervous system involvement by leukemia, not be on certain medications affecting enzyme CYP3A4/5, and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing the effectiveness of adding M3814 to standard chemotherapy drugs (mitoxantrone, etoposide phosphate, cytarabine) in patients with relapsed/refractory acute myeloid leukemia. It aims to find the best dose of M3814 and monitor its side effects when combined with these chemotherapies.See study design

What are the potential side effects?

Potential side effects include reactions related to cell growth inhibition by M3814 and typical chemotherapy effects like nausea, fatigue, hair loss except alopecia resolved to grade <=1 per NCI criteria. Organ inflammation and blood disorders may also occur.

Eligibility Criteria

Inclusion Criteria

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

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My cancer did not fully respond to initial treatment cycles aimed at remission.

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My heart is strong enough for treatment, and I haven't had too much of a certain cancer drug.

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All my side effects from previous cancer treatments, except hair loss, are mild or gone.

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I am 18 years old or older.

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I am mostly self-sufficient and can carry out daily activities.

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I have been diagnosed with AML, not including the type known as APL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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

Secondary outcome measures

Duration of CR/CRi (DOR)

Event-free survival (EFS)

Overall response rate

+2 more

Other outcome measures

Effect of cytogenetic and molecular abnormalities

Pharmacodynamic effects of M3814 in combination with MEC

Rate of allogeneic hematopoietic cell transplantation (HCT)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (peposertib, mitoxantrone, etoposide, cytarabine)Experimental Treatment4 Interventions

Patients receive peposertib PO BID on days 2-21, mitoxantrone IV over 15 minutes, etoposide IV over 60 minutes and cytarabine IV over 60 minutes on days 1-5 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Etoposide Phosphate

2011

Completed Phase 2

~160