NCT00038805 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS) (NCT00038805)

Trial Description
Primary Objective:

  • To determine the safety and maximum tolerated dose of gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) as part of an intensive but nonmyeloablative preparative regimen in older or medically infirm patients undergoing mini-allogeneic peripheral blood stem cell transplantation

Secondary Objectives:

  • To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy.
  • To evaluate disease-free and overall survival and relapse rates.
  • To evaluate the need and ability to give multiple cycles of gemtuzumab ozogamicin plus FA and mobilized DLI in patients not achieving complete remission.

This trial is sponsored by M.D. Anderson Cancer Center. [1]

Study Data

  • Condition: Leukemia
  • Interventions:
  • Phase: II & III
  • Enrollment: 3
  • Start: May 2001
  • Completion: November 2004
  • Last verified: July 2012

Study Schematic

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Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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