Study on Fractionated Gemtuzumab Ozogamicin for Treating Residual Disease in Acute Myeloid Leukemia Patients

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03737955

Provider View

This clinical trial is testing how well a drug called gemtuzumab ozogamicin works in treating small amounts of remaining cancer cells in patients with acute myeloid leukemia (AML). The drug targets specific cancer cell markers to deliver chemotherapy directly to them.

Patient Parameters

Program Overview

This study is exploring the effectiveness of a drug called gemtuzumab ozogamicin in treating patients with acute myeloid leukemia (AML) who have small amounts of cancer cells left after initial treatment. Gemtuzumab ozogamicin is a targeted therapy that attaches to CD33 receptors on cancer cells and delivers chemotherapy to kill them. The trial aims to see if this approach can help reduce the remaining cancer cells.

Description

In this study, patients will receive the drug gemtuzumab ozogamicin through an IV on days 1, 4, and 7. This treatment cycle lasts for 35 days, as long as the disease does not get worse and there are no severe side effects. If patients respond well or do not have significant side effects, they may receive a second round of treatment within 60 days after the first one. After finishing the treatment, patients will be monitored for 6 months to check their health and response to the therapy.

Eligibility Criteria

Inclusion Criteria

  • Must have been previously diagnosed with acute myeloid leukemia (AML), but not acute promyelocytic leukemia (APL) or biphenotypic AML.
  • Must have small amounts of cancer cells left, known as measurable residual disease (MRD), and meet criteria for complete response or remission with incomplete blood recovery.
  • MRD must be detectable by specific lab tests and confirmed by a central laboratory.
  • Must have received at least one cycle of standard chemotherapy before joining the study.
  • Must be 18 years or older.
  • Must have a performance status score of 3 or lower, indicating ability to perform daily activities with some limitations.
  • Cancer cells must have CD33 markers.
  • Must have acceptable kidney and liver function based on specific blood tests.
  • Must be able to provide written consent to participate.
  • Women of childbearing age must have a negative pregnancy test before starting treatment.
  • If re-enrolling, must have achieved MRD-negative complete response in previous participation.

Exclusion Criteria

  • Cannot have had chemotherapy or radiation therapy within 14 days before starting the study.
  • Cannot be taking other experimental drugs.
  • Cannot have uncontrolled illnesses such as infections, heart failure, unstable chest pain, irregular heartbeats, or mental health issues that would interfere with the study.

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