Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS (NCT00038831)
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).
- 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.
- 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. 
- Acute Myelogenous Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Chronic Lymphocytic Leukemia (CLL)
- Phase: I & II
- Enrollment: 47
- Start: May 2001
- Completion: October 2006
- Last verified: July 2012
Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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