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Anti-metabolites
Azacitidine + Venetoclax + NK Cells for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Abhishek Maiti, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial tests if adding NK cells to treat AML (a type of cancer) can help control it.
Who is the study for?
This trial is for adults diagnosed with Acute Myeloid Leukemia (AML) or related conditions, who have relapsed or don't respond to standard treatments. It's also open to older patients unfit for intensive chemotherapy. Participants must not have certain infections, severe heart issues, other active cancers, or be pregnant. They should agree to use contraception and understand the study.Check my eligibility
What is being tested?
The trial tests if adding Natural Killer (NK) cells from healthy donors to Azacitidine and Venetoclax treatment can better control AML. NK cells are part of the immune system that helps fight cancer.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea, liver problems like jaundice, kidney issues such as reduced urine output, blood disorders like anemia or clotting problems, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Dose Expansion to evaluate the combination of azacitidine, venetoclax and allogeneic NK cells in older/unfit participants with AML ineligible for intensive chemotherapy or allogeneic stem-cell transplantation (allo SCT).
Group II: Dose EscalationExperimental Treatment3 Interventions
Dose Escalation to evaluate the combination of azacitidine, venetoclax and allogeneic NK cells in older/unfit participants with AML ineligible for intensive chemotherapy or allogeneic stem-cell transplantation (allo SCT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
NK Cells
2020
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,442 Total Patients Enrolled
Abhishek Maiti, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe stomach or metabolic issues affecting medication absorption.I do not have any health, mental, or social issues that would affect my study participation.I do not have active hepatitis B, hepatitis C, or HIV.My heart's electrical activity is abnormal, or I've had Torsades de pointes.I agree to use birth control during and after the study for the time required.My cancer has a specific genetic abnormality.I have not experienced symptoms related to brain or nerve issues recently.I have a history of certain blood disorders but haven't had specific treatments for MDS.I have had major surgery recently or a significant wound that hasn't healed.I have had another type of cancer.I do not have uncontrolled or symptomatic leukemia in my brain.I have been diagnosed with AML or MDS/AML with 10-19% blasts.I have not taken high-dose steroids or immunosuppressants recently.I weigh less than 50 kg.I had a stem cell transplant, recovered from side effects, and have minimal chronic GVHD.I am older or unfit, with a new high-risk AML or MDS/AML diagnosis, and can't undergo intensive chemotherapy or a stem cell transplant.My liver and kidneys work well, and I can understand and sign a consent form.I have tried all FDA-approved treatments for my cancer's specific mutations.I have an ongoing infection that hasn't improved with treatment.I do not have severe heart failure or uncontrolled heart rhythm problems.I am over 18 with relapsed or resistant AML/MDS, not including APL or CBF AML, and no standard treatments are available for me.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion
- Group 2: Dose Escalation
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.
To what extent can Dose Escalation be detrimental to the wellbeing of participants?
"Dose Escalation's safety is based on limited evidence, so we assigned it a score of 1."
Answered by AI
Is the recruitment phase for this research currently taking place?
"According to the information provided on clinicaltrials.gov, this experiment is no longer recruiting participants as its last update was dated April 17th 2023. On a brighter note, there are still 1573 medical trials actively seeking candidates at present."
Answered by AI
Can elderly individuals over the age of eighty-five participate in this research?
"Those who are over eighteen and below seventy-five years of age may be eligible for this experiment."
Answered by AI
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