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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Complete remission (CR) rate
Incidence of adverse events
Overall survival
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
Find a Location
Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,505 Previous Clinical Trials
11,340,248 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,109 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,187 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active hepatitis, HIV, or a history of substance abuse.I have had a menstrual period in the last 12 months.I am taking hydroxyurea for high blast count and can continue it during my first therapy cycle.I am undergoing leukapheresis for high white blood cell count.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 14 days and have recovered from any side effects.My medication's effects have lasted for its full duration as determined by the pharmacy.I have stopped taking any unknown medications for at least 14 days.My blood pressure is not well-controlled.I have unstable chest pain.My heart condition is not severe and mostly doesn't limit my daily activities.I do not have an uncontrolled serious heart rhythm problem.I do not have an ongoing infection that isn't under control.I do not have any serious illness or condition that could make this study unsafe for me.I can care for myself but may not be able to do active work.My blood clotting tests are within normal range, considering my condition.My kidney function, measured by creatinine levels or clearance, is within the required range.I have not had surgery to remove my uterus or both ovaries.I have AML with specific genetic changes or high levels of certain proteins.My AML cancer has either come back after treatment or didn't respond to the first treatment.I have AML with specific genetic changes or high levels of certain proteins.I do not have acute promyelocytic leukemia.I do not have leukemia in my brain or spinal cord.I do not have leukemia outside of my bone marrow.I have not been treated with nintedanib or any VEGFR inhibitor.I am not allergic to nintedanib or 5-azacitidine.I am not eligible for or have chosen not to undergo intensive therapy.I agree to use effective birth control during and 3 months after the study.I have AML that developed after previous blood issues or cancer treatments.I have had major surgery or a serious injury in the last 4 weeks without complete healing.I have had significant protein in my urine in the last month.I do not have serious heart conditions.I have had a heart attack in the last year.I have fluid around my heart.I am not on blood thinners that need INR monitoring, except for low-dose aspirin.I have HIV but don't need treatments that would interfere with the study drugs.I am not currently being treated for another cancer.I do not have any uncontrolled illnesses.I am not pregnant or nursing.I can swallow oral gel capsules.I do not have stomach or intestine problems that affect medication absorption.My cancer has a specific genetic change in the MLL gene.My AML has returned or is not responding to treatment.My cancer has come back after being in complete remission.I have newly diagnosed or relapsed/refractory AML.My initial cancer treatment did not fully clear the cancer.I have been newly diagnosed with AML.My cancer has a specific genetic change involving 11q23.My leukemia has the FLT3-ITD mutation.My bone marrow shows high levels of HOX gene activity.My cancer has a specific genetic change in the MLL gene.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nintedanib, azacitidine)
Awards:
This trial has 3 awards, including:- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment capacity of this research study?
"Indeed, the information on clinicaltrials.gov indicates that this investigation is actively recruiting participants. First published on November 14th 2018 and last updated April 30 2021, it requires 44 patients from a single centre to complete the study."
Answered by AI
For what health conditions is Nintedanib typically prescribed?
"Nintedanib is prescribed to regulate the amount of neutrophils and platelets in a patient's body. It can also be employed as an alternative treatment for anemia, refractory anemia, systemic scleroderma and other related ailments."
Answered by AI
Are there other precedents of research into Nintedanib's effects?
"Currently, the number of live trials exploring Nintedanib stands at 239 with 40 in Phase 3. Additionally, 12798 locations are conducting research on Nintedanib across the globe though there is a concentration in Saint Louis Missouri."
Answered by AI
Has the Food and Drug Administration (FDA) granted clearance for Nintedanib?
"As Nintedanib is in Phase 1 of clinical trials, there has only been minor data to support its safety and efficacy. Therefore, it was given a score of 1."
Answered by AI
Are there available openings for volunteers in this clinical trial?
"Clinicaltrials.gov suggests that this medical trial is presently recruiting participants, with its first posting on November 14th 2018 and most recent update being April 30th 2021."
Answered by AI
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