Study on Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Acute Myeloid Leukemia (AML) That Has Returned or Not Responded to Treatment

Sponsor: Stanford University

Sponsor score: 40

ClinicalTrials ID:NCT06561152

This clinical trial is testing a combination of the drug tagraxofusp with low-intensity chemotherapy drugs cladribine and cytarabine to see if it can effectively treat patients with CD123-positive acute myeloid leukemia (AML) that has come back or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a new treatment combination works for patients with CD123-positive acute myeloid leukemia (AML) that has either returned after treatment or not responded to previous therapies. The treatment involves using tagraxofusp along with low-intensity chemotherapy drugs cladribine and cytarabine.

Eligibility Criteria

Exclusion Criteria

  • Have received previous therapy other than Venetoclax combined with a hypomethylating agent, or Venetoclax followed by IDH or FLT3 inhibitors.
  • Have had any anti-cancer treatment within 14 days before starting the study treatment. However, hydroxyurea is allowed during the first cycle if needed to control the disease.
  • Have significant heart problems, such as severe heart failure, recent heart attack, or uncontrolled high blood pressure.
  • Have any uncontrolled infections, whether bacterial, fungal, or viral.
  • Have HIV or active hepatitis B or C infections.
  • Have ongoing severe side effects from previous treatments that are not easily managed, except for hair loss, nausea, and fatigue.
  • Have another active cancer or a history of cancer that could interfere with the study results. Certain non-threatening cancers like non-melanoma skin cancer or localized prostate cancer are exceptions.
  • Have uncontrolled lung diseases that could increase the risk of complications during the study.
  • Have known or suspected active disease in the central nervous system (CNS).
  • Are taking immunosuppressive medications, except for low-dose prednisone (10 mg/day or less).
  • Have had an allogenic stem cell transplant before the treatment.
  • Have any other uncontrolled illnesses or conditions that could interfere with the study, including severe infections or psychiatric issues.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Stanford University94304Palo AltoCalifornia

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