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Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure

Sponsored by Brian Jonas

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified May 29, 2024

Phase

Clinical Trial

Sponsor

Brian Jonas

Enrollment Target

20

Start Date

Feb 2022

πŸ“Š
1 of 20 participants interested
5% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Who Can Participate

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent
Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016)
Age \>= 18 years
Treatment naΓ―ve and eligible for venetoclax plus HMA: \
Age \>= 75 OR \
Age \>= 18-74 with at least one of the following co-morbidities: \*\
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 \*\
Cardiac history of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) =\< 50% or chronic unstable angina \*\
Carbon monoxide diffusing capability (DLCO) =\< 65% or forced expiratory volume in 1 second (FEV1) =\< 65% \*\
Creatinine clearance \>= 30 mL/min to =\< 45 mL/min \*\
Moderate hepatic impairment with total bilirubin \> 1.5 to =\< 3 x upper limit of normal (ULN) \*\
Any other situation that the investigator judges to be incompatible with intensive chemotherapy must be reviewed with the study chair before study enrollment

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

20 participants

⚧

Gender

ALL

🏒

Sponsor

Brian Jonas

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Clovis

California

Location available
View Clovis location page
NOT_YET_RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Sacramento

California

Location available
View Sacramento location page
NOT_YET_RECRUITING

Oklahoma City

Oklahoma

Location available
View Oklahoma City location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Acute Myeloid Leukemia Treatment in Clovis?

Join others in California exploring innovative treatment options through clinical research

Acute Myeloid Leukemia Treatment Options in Clovis, California

If you're searching for Acute Myeloid Leukemia treatment in Clovis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Clovis, Los Angeles, Sacramento and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Acute Myeloid Leukemia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Acute Myeloid Leukemia?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Acute Myeloid Leukemia

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Acute Myeloid Leukemia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04905810. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.