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Tagraxofusp and Azaxitadine With or Without Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents

(TAGALONG)

Sponsored by Joshua Zeidner

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Jan 23, 2026

Phase

Clinical Trial

Sponsor

Joshua Zeidner

Enrollment Target

53

Start Date

May 2024

๐Ÿ“Š
1 of 53 participants interested
2% 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

A treatment cycle is 28 days for Cycle 1 and Cycle 2. Tagraxofusp will be administered at 12 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 5 consecutive days (or 5 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution). Subjects with a marrow CR (See the protocol) after Cycle 2 will continue Tagraxofusp for Cycles 3 to 12 (up to 1 year of treatment) at 12 mcg/kg IV for 5 consecutive days every 28 days.

Who Can Participate

Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to participate in this study:
Subjects must have newly diagnosed, untreated AML, as defined by โ‰ฅ 20% blasts in peripheral blood or bone marrow by manual aspirate differential, immunohistochemistry staining, or flow cytometry, as defined by standard WHO 2016 diagnostic criteria.
Subjects must have documented CD123 positivity on leukemia cells by a centralized flow cytometry assay (Hematologics).
Documented diagnosis of prior MDS, CMML, MDS/MPN overlap syndromes, or MPN's according to WHO criteria. Subjects must have received at least 2 cycles of hypomethylating agents (azacitidine or decitabine or oral decitabine/cedazuridine) for the management of MDS, CMML, MDS/MPN overlap syndromes, or MPN's. NOTE: Subjects who have enrolled on clinical trials with investigational agents in combination with HMA's will still be eligible. Investigational agents must have been discontinued \>21 days prior to

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

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

53 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Joshua Zeidner

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Orlando

Florida

Location available
View Orlando location page
RECRUITING

Buffalo

New York

Location available
View Buffalo location page
RECRUITING

Chapel Hill

North Carolina

Location available
View Chapel Hill location page
RECRUITING

Winston-Salem

North Carolina

Location available
View Winston-Salem location page
RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page
RECRUITING

Providence

Rhode Island

Location available
View Providence 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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Find More Leukemia Trials by City

Browse all leukemia clinical trials in these cities โ€” not just this study.

Looking for Acute Myeloid Leukemia Treatment in Miami?

Join others in Florida exploring innovative treatment options through clinical research

Acute Myeloid Leukemia Treatment Options in Miami, Florida

If you're searching for Acute Myeloid Leukemia treatment in Miami, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Miami, Orlando, Buffalo 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 Florida
Now Enrolling
Up to 53 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Acute Myeloid Leukemia?

Potential Benefits

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

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’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: NCT05442216. 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.