Tagraxofusp to Eradicate Measurable Residual Disease in Patients With Acute Myeloid Leukemia

NCT05720988 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-08

No results posted yet for this study

Summary

This phase Ib/II trial tests the safety of tagraxofusp when given with or without azacitidine in patients with acute myeloid leukemia in remission with measurable residual disease who will undergo allogeneic hematopoietic cell transplant. Tagraxofusp is a recombinant protein consisting of IL-3 conjugated to a truncated diptheria toxin. The IL-3 attaches to the cancer cells and the toxic substance kills them. Azacitidine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Tagraxofusp and azacitidine may work better to kill cancer cells and eradicate measurable residual disease in patients with acute myeloid leukemia.

Conditions

Interventions

DRUG

Azacitidine

Given SC

BIOLOGICAL

Tagraxofusp-erzs

Given IV

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    collaborator INDUSTRY
  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Caspian Oliai, MD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2025-08-03
Completion
2026-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720988 on ClinicalTrials.gov