Overview

Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome. Primary Objective: 1. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation. Secondary Objectives: 1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy. 2. To evaluate the incidence and severity of GVHD in this population 3. To evaluate disease-free and overall survival and relapse rates.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Antilymphocyte Serum
Fludarabine
Fludarabine phosphate
Gemtuzumab
Melphalan
Thymoglobulin
Vidarabine