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Anti-metabolites
M3814 + Chemotherapy for Acute Myeloid Leukemia
Phase 1
Recruiting
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)
Must not have
Patients must not have documented active central nervous system (CNS) involvement by leukemia. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs)
Patients must not have known significant cardiopulmonary disease defined as:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called M3814 combined with three chemotherapy drugs to treat patients with a difficult type of leukemia. The new drug blocks cancer cell growth, and the chemotherapy drugs kill or stop the cancer cells.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have leukemia affecting my brain.
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I do not have serious heart or lung disease.
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I haven't taken any experimental or new treatments for my leukemia in the last 14 days or less, except for treatments to control white blood cell counts.
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I haven't taken strong medication affecting liver enzymes for at least 3 weeks.
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I have never been treated with MEC.
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I am not taking sorivudine or similar drugs.
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I do not have severe heart failure.
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I am not taking medications that affect my heart's electrical cycle.
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I haven't had a live vaccine or an active infection in the last 30 days.
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My heart's electrical cycle is longer than normal.
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I have unstable chest pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
Secondary study objectives
Duration of CR/CRi
Event-free survival
Overall response rate
+2 moreOther study objectives
Effect of cytogenetic and molecular abnormalities
Pharmacodynamic effects of M3814 in combination with MEC
Rate of allogeneic hematopoietic cell transplantation (HCT)
+1 moreAwards & 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 (peposertib, mitoxantrone, etoposide, cytarabine)Experimental Treatment8 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. Additionally, patients undergo ECHO and MUGA during baseline, and blood collection and bone marrow biopsy throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Cytarabine
2016
Completed Phase 3
~4020
Etoposide Phosphate
2011
Completed Phase 2
~160
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Peposertib
2021
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and enzyme inhibitors. Chemotherapy drugs like cytarabine and daunorubicin work by killing rapidly dividing cells, which include cancer cells.
Targeted therapies, such as FLT3 inhibitors, specifically target mutations in cancer cells, thereby reducing damage to normal cells. Enzyme inhibitors, like the investigational drug M3814, block specific enzymes necessary for cancer cell growth and survival.
This is crucial for AML patients as it offers a more precise treatment approach, potentially reducing side effects and improving outcomes by directly targeting the molecular abnormalities driving the leukemia.
Progress in the problem of relapsed or refractory acute myeloid leukemia.Molecular targeting in acute myeloid leukemia.Targeting phosphatidylinositol 3-kinase signaling in acute myelogenous leukemia.
Progress in the problem of relapsed or refractory acute myeloid leukemia.Molecular targeting in acute myeloid leukemia.Targeting phosphatidylinositol 3-kinase signaling in acute myelogenous leukemia.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,532 Total Patients Enrolled
Brian A JonasPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
3 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer did not fully respond to initial treatment cycles aimed at remission.I am on blood thinners but my platelet count is above 30,000.I do not have leukemia affecting my brain.My heart is strong enough for treatment, and I haven't had too much of a certain cancer drug.I cannot stop taking my proton-pump inhibitors without consulting my doctor.I had a bone marrow transplant over 3 months ago and don't have ongoing immune issues.I do not have serious heart or lung disease.My condition is relapsed or refractory acute myeloid leukemia.All my side effects from previous cancer treatments, except hair loss, are mild or gone.I can avoid grapefruit and Seville oranges during my treatment.I haven't taken any experimental or new treatments for my leukemia in the last 14 days or less, except for treatments to control white blood cell counts.I can stop taking certain medications or herbal supplements that affect how drugs are processed in my body.I am HIV positive but on effective treatment, with no AIDS history, and if applicable, my hepatitis is under control.I haven't taken any medications that are sensitive to specific liver enzymes within a day before starting M3814.I haven't taken strong medication affecting liver enzymes for at least 3 weeks.I have never been treated with MEC.I am 18 years old or older.I am not taking sorivudine or similar drugs.My leukemia has returned after a short remission.I do not have severe heart failure.I am not taking medications that affect my heart's electrical cycle.I have stomach or bowel problems that could affect how a medicine works in my body.I am mostly self-sufficient and can carry out daily activities.I haven't had a live vaccine or an active infection in the last 30 days.I haven't taken strong inhibitors of CYP3A4/5, CYP2C9, and CYP2C19 for at least a week before starting M3814.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I have risk factors for a specific heart rhythm problem.My heart's electrical cycle is longer than normal.I am not pregnant and agree to use birth control during and 3 months after the study.I haven't had a heart attack in the last 6 months.I have another cancer type, but it won't affect this trial's treatment.I have unstable chest pain.I have been diagnosed with AML, not including the type known as APL.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (peposertib, mitoxantrone, etoposide, cytarabine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.