NCT00038831 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS (NCT00038831)

Trial Description
The goal of this clinical research study is to find the highest safe dose of the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. In this clinical rial, researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia (CML), or myelodysplastic syndrome (MDS).

Primary Objective:

  • To determine the safety and maximum tolerated dose (MTD) of gemtuzumab ozogamicin as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation.

Secondary Objectives:

  • To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy.
  • To evaluate the incidence and severity of graft-versus-host disease (GVHD), a possible complication of high dose cancer treatment,  in this population
  • To evaluate disease-free and overall survival and relapse rates.

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

Study Data

  • Condition:
    • Acute Myelogenous Leukemia (AML)
    • Myelodysplastic Syndrome (MDS)
    • Chronic Lymphocytic Leukemia (CLL)
  • Interventions:
  • Phase: I & II
  • Enrollment: 47
  • Start: May 2001
  • Completion: October 2006
  • Last verified: July 2012

Study Schematic

(Coming soon)

Click here to Return to Drug map

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

Copyright © 2015 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Add to Flipboard Magazine.