Study on Gemtuzumab Ozogamicin for Treating Patients with Relapsed or Hard-to-Treat Acute Myeloid Leukemia or Acute Promyelocytic Leukemia

Sponsor: Wake Forest University Health Sciences

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01869803

Provider View

This clinical trial is testing the drug gemtuzumab ozogamicin to see if it can help patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL) that has returned or is not responding to standard treatments. The drug uses antibodies to target and kill cancer cells.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of gemtuzumab ozogamicin in treating patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL) that has come back or is not responding to other treatments. This drug works by using antibodies to find and destroy cancer cells or deliver cancer-killing substances directly to them.

Description

The main goals of this study are to provide access to gemtuzumab ozogamicin (Mylotarg) for patients with AML or APL who have no other treatment options and to monitor the safety of the drug in these patients.

Patients will receive gemtuzumab ozogamicin through an IV infusion over two hours on days 1 and 15 of the treatment cycle. After completing the treatment, patients will have follow-up visits every month for one year to monitor their health and any effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or hard-to-treat acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL) and not eligible for standard treatments.
  • Initial diagnosis of AML, biphenotypic acute leukemia, or APL.
  • Cancer cells must have a CD33 marker present in more than 30% of cells.
  • Must be in relatively good health with an ECOG performance status of 3 or less, or a Karnofsky score above 60%.
  • Normal liver function tests within specified limits.
  • It is considered ethical to provide this experimental drug, which may affect the liver and bone marrow.
  • Women and men of childbearing potential must agree to use effective birth control during treatment.
  • Must be able to understand and sign a consent form approved by the Institutional Review Board (IRB).

Exclusion Criteria

  • Currently receiving other experimental treatments for leukemia.
  • Have untreated hepatitis C.
  • Have uncontrolled illnesses, including active liver disease or psychiatric conditions that would affect participation.
  • Pregnant women cannot participate, and breastfeeding must be stopped if treated with Mylotarg.
  • HIV-positive patients on antiretroviral therapy are not eligible.
  • Known allergy to gemtuzumab ozogamicin or its components.

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