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Anti-metabolites

Azacitidine + Venetoclax for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Dan Pollyea

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula

Subject must be ≥ 60 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of study enrollment to one year after enrollment

Awards & highlights

Study Summary

This trial is testing a new treatment for elderly patients with acute myeloid leukemia who have not received previous treatment. The new treatment is a combination of drugs called azacitidine and venetoclax.

Who is the study for?

This trial is for elderly patients (≥60 years old) with newly diagnosed acute myeloid leukemia (AML), who can't or won't undergo standard treatment due to health issues. They must have a life expectancy of at least 12 weeks, be able to perform daily activities with minimal assistance (ECOG ≤2), and have proper kidney and liver function. Men and postmenopausal or surgically sterile women must agree to use contraception.Check my eligibility

What is being tested?

The study tests azacitidine combined with venetoclax as an initial ('induction') therapy followed by maintenance doses of venetoclax alone in elderly AML patients who respond well to the first phase. The goal is to see if this regimen is effective when standard treatments aren't suitable.See study design

What are the potential side effects?

Potential side effects may include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding, fatigue, and possible liver abnormalities. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

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I am 60 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My liver tests are within normal limits, except for Gilbert's syndrome.

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I am a woman over 55 with no periods for 12 months or have had surgery to remove my ovaries or uterus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study enrollment to one year after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study enrollment to one year after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study enrollment to one year after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of response to azacitidine and venetoclax treatment

Secondary outcome measures

Azacitidine

Hematologic Toxicity as defined by the 2017 ELN AML Recommendations

Azacitidine

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Azacitidine and VenetoclaxExperimental Treatment1 Intervention

On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,541 Total Patients Enrolled

Dan PollyeaPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03466294 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Azacitidine and Venetoclax

Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT03466294 — Phase 2

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03466294 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other instances in which Azacitidine and Venetoclax have been studied together?

"350 medical studies are currently underway to research azacitidine and venetoclax. Of these, 55 are in phase 3. Most of the clinical trials for these drugs are based out of Edmonton, Alberta; however, there are 11288 total locations running trials for these medication across the globe."

Answered by AI

What is the maximum patient volume for this research project?

"At the moment, this clinical trial has paused recruitment. The study was originally posted on May 15th, 2018 and was last edited on August 1st, 2022. There are presently 1592 studies actively searching for patients with leukemia, myeloid and 350 studies for Azacitidine and Venetoclax admitting patients."

Answered by AI

Are new participants currently being sought for this experiment?

"This study is not recruiting at this time, according to the latest update on clinicaltrials.gov from August 1st, 2022. The trial was first posted on May 15th, 2018. If you are looking for other studies involving leukemia, myeloid or Azacitidine and Venetoclax, there are 1592 and 350 trials actively recruiting patients respectively."

Answered by AI

What are some common uses for the drugs Azacitidine and Venetoclax?

"Azacitidine and Venetoclax is most often used as part of an induction chemotherapy regimen. Additionally, this medication can be effective in treating refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."

Answered by AI