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Anti-metabolite

Navtemadlin + Chemotherapy for Acute Myeloid Leukemia

Los Angeles, CA

Phase 1

Waitlist Available

Led By Kevin R Kelly

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 be considered candidates for intensive chemotherapy treatment with standard doses of cytarabine and idarubicin ("7+3 regimen").

All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy, except alopecia, must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade =< 2 prior to starting therapy.

Must not have

Use of any medications considered inhibitors or

Patients with history of bleeding diathesis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing navtemadlin in combination with standard chemotherapy drugs to treat acute myeloid leukemia. Navtemadlin works by blocking a protein called MDM2 that is needed for cell growth. Chemotherapy drugs work in different ways to stop the growth of cancer cells. Giving navtemadlin with chemotherapy drugs may stabilize cancer for longer.

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Who is the study for?

This trial is for adults with newly diagnosed, untreated Acute Myeloid Leukemia (AML) that's not acute promyelocytic leukemia. They must have a specific protein (wild-type p53), be fit for intensive chemo, and have good heart function and organ health. People with HIV can join if their treatment is effective. Pregnant or breastfeeding women can't join, nor those unwilling to use contraception.Check my eligibility

What is being tested?

The trial tests Navtemadlin combined with standard chemotherapy drugs Cytarabine and Idarubicin in AML patients. It aims to find the best dose of Navtemadlin and see how well it works alongside these chemotherapies by blocking a growth-essential protein in cancer cells.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system, blood disorders from chemotherapy agents like Cytarabine and Idarubicin, as well as potential risks associated with new drug Navtemadlin which may affect cell growth.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for intensive chemotherapy with cytarabine and idarubicin.

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All my side effects from previous treatments, except hair loss, are mild now.

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My kidney function tests are within normal limits.

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My heart pumps well, with an ejection fraction of 50% or higher.

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I have AML, not treated before, except for certain treatments if I had MDS before it became AML.

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My cancer has a normal p53 gene according to DNA tests.

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I can take care of myself but might not be able to do heavy physical work.

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Exclusion Criteria

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

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I am not taking any drugs that strongly affect other medications.

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I have a history of unusual bleeding.

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I haven't taken specific strong medications like alfentanil or quinidine in the last 14 days.

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I am not pregnant or breastfeeding.

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I am not willing to use birth control during the study.

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My cancer has a p53 mutation or deletion.

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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

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

Pharmacokinetic (PK) profile of navtemadlin in combination with cytarabine and idarubicin

Other study objectives

Complete cytogenetic response to navtemadlin, cytarabine and idarubicin

Complete response rate to navtemadlin, cytarabine and idarubicin

Progression-free survival (PFS)

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 (navtemadlin, cytarabine, idarubicin)Experimental Treatment3 Interventions

Patients receive navtemadlin PO QD on days 1-7, cytarabine IV BID over 3 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with residual disease may receive cytarabine IV BID over 3 hours for 5 days and idarubicin IV over 10-15 minutes for 2 days starting between days 14-21 of cycle 1 or the second cycle of navtemadlin, cytarabine, and idarubicin. Patients who achieve a CR or a CRi in either cycle 1 or 2 may receive cytarabine IV BID over 3 hours on days 1, 3, and 5 for 3-4 additional 28 to 35-day cycles 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

~4020

Idarubicin Hydrochloride

2013

Completed Phase 1

~50