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Nucleoside Analog
Enasidenib + Azacitidine for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Courtney DiNardo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
AML patients with prior history of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) regardless of prior therapy received, are eligible at the time of diagnosis of AML
Subjects must have documented IDH2 gene mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies a combination of drugs for patients with leukemia who have a specific gene mutation. The drugs may stop the growth of cancer cells by blocking enzymes needed for cell growth.
Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) or related conditions, who have failed previous treatments or are not eligible for intensive chemotherapy. Participants must have an IDH2 gene mutation, be able to perform daily activities (ECOG <=3), and have acceptable liver and kidney function. Women of childbearing age must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of enasidenib mesylate combined with azacitidine in patients with AML that has returned after treatment or hasn't responded at all. These drugs may inhibit enzymes that cancer cells need to grow.See study design
What are the potential side effects?
Potential side effects include liver problems, digestive issues like nausea or constipation, fatigue, blood cell count changes leading to increased infection risk or bleeding tendencies, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AML and previously had MDS or CMML.
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My cancer has an IDH2 gene mutation.
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My kidney function is good, with creatinine levels below 2.
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I am not able to have children, am postmenopausal, or have a negative pregnancy test.
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I am a male and will use birth control during and for 3 months after the study.
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I am capable of limited self-care and spend less than half of my day in bed.
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I have AML or a type of leukemia with a myeloid component and previous treatments didn't work.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Disease-free survival (DFS)
Duration of response
Event-free survival
+2 moreOther outcome measures
Association of biomarkers to overall response
Change in markers over time
Minimal residual disease (MRD)
Side effects data
From 2023 Phase 1 trial • 48 Patients • NCT0203877767%
Pyrexia
67%
Pneumonia
33%
Enteritis infectious
33%
Hyperaesthesia teeth
33%
Nausea
33%
Infective tenosynovitis
33%
Bronchitis
33%
Bacteraemia
33%
Rhinitis
33%
Blood creatine phosphokinase increased
33%
Prothrombin time prolonged
33%
Dysgeusia
33%
Muscle spasms
33%
Auricular chondritis
33%
Small intestinal haemorrhage
33%
Malaise
33%
Oedema
33%
Influenza
33%
Nasopharyngitis
33%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy Cohort: PF-04449913 25 mg
Monotherapy Cohort: PF-04449913 50 mg
Monotherapy Cohort: PF-04449913 100 mg
Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg
Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin
Combination Cohort 3: PF-04449913 100 mg + Azacitidine
Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg
Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, enasidenib mesylate)Experimental Treatment2 Interventions
Patients receive azacitidine SC or IV over 30 minutes on days 1-7 and enasidenib mesylate PO QD beginning on day 1. Cycles repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,346 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,082 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
659 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe ongoing health issues like uncontrolled infections, high blood pressure, heart failure, or irregular heartbeats.I am over 60 and have AML but can't undergo intensive chemotherapy.I have AML and previously had MDS or CMML.My cancer has an IDH2 gene mutation.My kidney function is good, with creatinine levels below 2.I may have taken hydroxyurea or cytarabine for my fast-growing disease before starting the study, as advised.My leukemia is of a specific type known as acute promyelocytic.I am not able to have children, am postmenopausal, or have a negative pregnancy test.My AML cancer is only outside the bone marrow.I am a male and will use birth control during and for 3 months after the study.I am capable of limited self-care and spend less than half of my day in bed.I have AML or a type of leukemia with a myeloid component and previous treatments didn't work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (azacitidine, enasidenib mesylate)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What regulatory approval has Enasidenib Mesylate received?
"Enasidenib Mesylate is still being tested for efficacy in clinical trials, but early data suggests that it is safe. Our team at Power gave it a score of 2."
Answered by AI
Can you share what Enasidenib Mesylate is most commonly used to treat?
"Enasidenib Mesylate, while typically used to treat communicable diseases, can also help patients who suffer from conditions like neutropenia and/or thrombocytopenia, anemia, or refractory anemia."
Answered by AI
What is the maximum sample size for this clinical trial?
"That is correct, the listing on clinicaltrials.gov currently advertises that this study is open for recruitment. This particular trial was first posted on September 18th, 2018 and received its most recent update on May 9th, 2022. The research team hopes to enroll 50 individuals at a single location."
Answered by AI
Are there any patients who can still join this clinical trial?
"Clinicaltrials.gov reports that this trial is currently looking for participants. The listing was first created on September 18th, 2018 and edited most recently on May 9th, 2022."
Answered by AI
What are some other circumstances in which Enasidenib Mesylate has been studied?
"At the current moment, there are 226 ongoing clinical trials for Enasidenib Mesylate globally. Of those, 49 are in Phase 3 and 8746 locations are running at least one trial."
Answered by AI
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