Study on Gemtuzumab Ozogamicin and Donor Blood Cells for Treating Difficult Cases of Acute Myeloid Leukemia

Sponsor: Brown University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03374332

Provider View

This clinical trial is exploring a new treatment approach for patients with acute myeloid leukemia that has returned or not responded to standard treatments. The study investigates whether a drug called Gemtuzumab Ozogamicin, followed by an infusion of donor blood cells, can help the immune system fight the leukemia.

Patient Parameters

Program Overview

This study is for patients with acute leukemia that has come back or hasn't responded to standard treatments. Researchers are testing if a drug called Gemtuzumab Ozogamicin, given along with donor blood cells, can help the immune system fight the leukemia. Gemtuzumab Ozogamicin is a type of drug that targets leukemia cells and is already approved for treating acute myeloid leukemia. The donor blood cell infusion is experimental and not yet proven to cure cancer. Initially, 6 patients will be treated to check the safety of this approach. If it's safe, up to 18 patients will be included in the study.

Eligibility Criteria

Exclusion Criteria

  • Infections like HIV, syphilis, hepatitis B or C, and others.
  • Uncontrolled diabetes. Controlled diabetes must be documented by a doctor.
  • Heart failure or heart problems. Approval from a heart specialist is needed.
  • Active chest pain (angina) or lung disease requiring oxygen.
  • History of blood cancers or other non-solid cancers.
  • Inability to give full informed consent.
  • Poor kidney or liver function.
  • History of liver disease or cirrhosis.
  • History of organ transplantation.
  • Donors with blood dilution issues affecting disease testing results.
  • Situations where blood loss and transfusions could affect disease testing results.

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