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Nucleoside analogues
Venetoclax + Azacitidine for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Amir T Fathi, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have pathologically confirmed, newly diagnosed acute myeloid leukemia (AML). The AML may be either: De Novo: AML in patients with no clinical history of prior myelodysplastic syndrome (MDS), myeloproliferative disorder, or exposure to potentially leukemogenic therapies or agents; Secondary AML (sAML): refers to an acute leukemic process (1) evolving from known prior myelodysplasia, myeloproliferative disorder, or aplastic anemia with or without treatment or; (2) as a product of previous exposure to a proven leukemogenic chemotherapeutic agent
The effects of venetoclax on the developing human fetus are unknown. For this reason and because other chemotherapeutic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should use contraceptives for at least 30 days following the last dose of venetoclax. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial will compare the efficacy of the investigational combination versus standard of care in patients with induction-eligible acute myeloid leukemia.
Who is the study for?
Adults diagnosed with newly confirmed acute myeloid leukemia (AML), either de novo or secondary, who are eligible for intensive chemotherapy. Participants must be over 18, have an ECOG performance status ≤2, adequate liver function and heart health, and not have received prior AML treatment except hydroxyurea for cytoreduction. They must agree to use contraception due to unknown effects of venetoclax on fetuses.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a combination therapy using azacitidine and venetoclax against standard induction chemotherapy options like cytarabine with idarubicin or daunorubicin, or liposomal daunorubicin and cytarabine in patients with acute myeloid leukemia.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems. There may also be liver issues indicated by abnormal tests results and potential heart problems such as irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with acute myeloid leukemia (AML) without previous cancer treatments.
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I agree to use effective birth control during and after the study.
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I have been newly diagnosed with acute myeloid leukemia (AML), without prior related diseases or treatments.
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My liver tests are within the normal range.
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My liver tests are within normal limits, except for conditions like Gilbert's syndrome.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time from randomization to time for up to 3 years, per protocol.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time from randomization to time for up to 3 years, per protocol.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival
Secondary outcome measures
100-Day post-transplant mortality
30-day mortality
60-day mortality
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Standard of Care (Conventional Induction)Experimental Treatment4 Interventions
Randomized participants will receive cytarabine and idarubicin [or daunorubicin) per standard of care as follows:
Induction: cytarabine on days 1-7 and idarubicin (or daunorubicin) on days 1-3 of induction.
Second Induction (if needed): Cytarabine on days 1-5 and idarubicin (or daunorubicin) on days 1-2 of re-induction.
Consolidation (if needed): If < 60 years, cytarabine days 1,3,5 of consolidation cycles, and if ≥60 years, cytarabine days 1-5 of consolidation cycles
Those with secondary or therapy-related AML can receive liposomal daunorubicin and cytarabine (Vyxeos) per standard of care as follows:
Induction: Liposomal daunorubicin and cytarabine (Vyxeos) on Days 1,3, 5 of induction.
Second Induction (if needed): Liposomal daunorubicin and cytarabine (Vyxeos) on days 1,3 of re-induction Consolidation (if needed): liposomal daunorubicin and cytarabine (Vyxeos) on days 1,3 of consolidation cycles
Group II: Investigational (Venetoclax and Azacitidine)Experimental Treatment2 Interventions
Participants will receive azacitidine on days 1-7 and venetoclax daily for up to (3) three 28-day study cycles and evaluated for response or benefit. If benefit/response is achieved, azacitidine on days 1-7 and venetoclax on days 1-28 (or less if deemed necessary per protocol) will be given in repeating 28-day cycles until benefit/response is no longer achieved or until patient proceeds to transplantation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
2013
Completed Phase 4
~4940
Cytarabine
2016
Completed Phase 3
~3310
Azacitidine
2012
Completed Phase 3
~1440
Idarubicin
2014
Completed Phase 4
~4330
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,218 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,309 Total Patients Enrolled
Amir T Fathi, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment for AML, except possibly hydroxyurea or ATRA.My AML is FLT3-mutated.I am under 60 and have AML with an NPM1 mutation.I refuse blood products or am allergic to them.My electrolyte levels are stable or being treated.I have an active hepatitis B or C infection.I have been newly diagnosed with acute myeloid leukemia (AML) without previous cancer treatments.I agree to use birth control during and after the study as required.I have AML and haven't had cancer treatments except possibly hydroxyurea or ATRA.I am not pregnant or breastfeeding, confirmed by a test.I haven't taken strong or moderate CYP3A inducers in the last 7 days.My white blood cell count is above 25 x 10^9/L.I do not have severe heart failure or significant heart dysfunction.I am allergic or react badly to the trial drugs or standard chemotherapy.I agree to use effective birth control during and after the study.I do not have GI conditions or surgeries that affect drug absorption.I have been newly diagnosed with acute myeloid leukemia (AML), without prior related diseases or treatments.I have symptoms related to leukemia in my brain, as assessed by my doctor.I have had chemotherapy or radiotherapy for AML, but not for therapy-related AML.I have not exceeded the safe limit for a specific cancer drug due to my treatment history.I had cancer before, but it's been 3 years and it was not likely to come back, or it was a minor skin cancer, cervical cancer in situ, or breast DCIS treated within the last 3 years.My liver tests are within the normal range.My liver tests are within normal limits, except for conditions like Gilbert's syndrome.I have been diagnosed with a specific type of leukemia that is considered to have a favorable outlook.I have a type of acute leukemia that doesn't fit into standard categories.I have been treated with drugs like azacitidine or decitabine before.I have had a bone marrow transplant for a blood cancer.My doctor says I can handle strong initial cancer treatment.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I do not have any severe illnesses that my doctors are still trying to control.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (Conventional Induction)
- Group 2: Investigational (Venetoclax and Azacitidine)
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 maladies is Azacitidine utilized to address?
"Azacitidine may prove to be a useful treatment for meningeal leukemia, induction chemotherapy, and acute myelocytic leukemia."
Answered by AI
Are there many locations where this research is being conducted within the state?
"Currently, 7 sites are actively accepting patients for this clinical trial. These locations include Charlotte, Sacramento and Philadelphia along with 4 other centers. To reduce the strain of traveling to a distant clinic, it is recommended that you choose one closest to your residence if possible."
Answered by AI
How many individuals are enrolled in this research endeavor?
"This clinical trial necessitates 172 participants who meet the outlined criteria. Patients may register for this medical study at Atrium Health Levine Cancer Institute in Charlotte, North carolina or University of California - Davis in Sacramento, California."
Answered by AI
Are there any vacancies still available for participation in this experiment?
"According to the clinicaltrials.gov data, this research endeavour is actively recruiting participants. The trial was launched on May 20th 2021 and has been revised most recently on November 16th 2022."
Answered by AI
Has the FDA authorized Azacitidine for commercial use?
"Due to the fact that this is a Phase 2 trial, where there are some data points reinforcing safety but no evidence in favor of efficacy, our team at Power rated Azacitidine's security as a 2 on their scale."
Answered by AI
To what extent have preceding clinical trials explored the use of Azacitidine?
"Presently, Azacitidine is being studied within 563 clinical trials. Of these studies, 109 are currently in the final phase of testing. Edmonton, Alberta serves as the epicentre for research on this medication; however, 22027 sites across the globe are running trials pertaining to it."
Answered by AI
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