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Nucleoside Metabolic Inhibitor

Nintedanib + Azacitidine for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Jessica Altman

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)

Note: Patients with secondary AML are eligible for enrollment into the trial (in both cohorts); secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndromes (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML

Must not have

Patients with known active or history of chronic hepatitis C and/or B infection, known HIV infection and active alcohol or drug abuse are not eligible.

- The ?5 half-lives? time period will be determined by investigational pharmacy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug, nintedanib, to see if it is effective in treating AML in older adults who cannot have standard intensive chemotherapy. The side effects of the combination will also be studied.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) showing HOX gene overexpression, FLT3-ITD, or specific genetic changes. Suitable candidates are those unfit for intensive chemotherapy, have an ECOG performance status of 0-3, and acceptable organ function tests. Women must not be pregnant and participants should agree to use contraception.

What is being tested?

The study is testing the combination of Nintedanib (not yet FDA-approved for AML) with Azacitidine (approved for a related blood cancer). The goal is to determine the right dose and side effects over six 28-day cycles, possibly followed by maintenance treatment unless adverse events occur.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, digestive issues like nausea or constipation, liver enzyme elevations indicating possible liver damage, increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I have had a menstrual period in the last 12 months.

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I have AML that developed after previous blood issues or cancer treatments.

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I can care for myself but may not be able to do active work.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I have not had surgery to remove my uterus or both ovaries.

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I have AML with specific genetic changes or high levels of certain proteins.

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My AML cancer has either come back after treatment or didn't respond to the first treatment.

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I have AML with specific genetic changes or high levels of certain proteins.

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I have newly diagnosed or relapsed/refractory AML.

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My cancer has a specific genetic change in the MLL gene.

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My cancer has come back after being in complete remission.

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My initial cancer treatment did not fully clear the cancer.

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I have been newly diagnosed with AML.

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My cancer has a specific genetic change involving 11q23.

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My bone marrow shows high levels of HOX gene activity.

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My cancer has a specific genetic change in the MLL gene.

Exclusion Criteria

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

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I do not have active hepatitis, HIV, or a history of substance abuse.

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My medication's effects have lasted for its full duration as determined by the pharmacy.

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My blood pressure is not well-controlled.

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I have unstable chest pain.

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My heart condition is not severe and mostly doesn't limit my daily activities.

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I do not have an uncontrolled serious heart rhythm problem.

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I do not have an ongoing infection that isn't under control.

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I have had significant protein in my urine in the last month.

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I do not have serious heart conditions.

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I have fluid around my heart.

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I am not on blood thinners that need INR monitoring, except for low-dose aspirin.

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I do not have acute promyelocytic leukemia.

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I do not have leukemia in my brain or spinal cord.

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I do not have leukemia outside of my bone marrow.

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I have not been treated with nintedanib or any VEGFR inhibitor.

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I am not allergic to nintedanib or 5-azacitidine.

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I have HIV but don't need treatments that would interfere with the study drugs.

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I am not currently being treated for another cancer.

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I am not pregnant or nursing.

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I can swallow oral gel capsules.

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I do not have stomach or intestine problems that affect medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Incidence of adverse events

Overall survival

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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 (nintedanib, azacitidine)Experimental Treatment3 Interventions

Participants receive nintedanib PO BID on days 1-28 and azacitidine IV or SC on days 1-7. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, participants may discontinue treatment, receive nintedanib every 4-8 weeks, or receive nintedanib and azacitidine every 4-8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

FDA approved

Tyrosine

FDA approved

0 / 37Eligibility criteria met