Phase II Trial of Clofarabine With Parenteral Busulfan (Busulfex®) Followed by Allogeneic Related or Unrelated Donor Transplantation for the Treatment of Hematologic Malignancies and Diseases
The success of allogeneic hematopoietic transplantation in the treatment of myeloid
malignancies is determined by two main factors: the limiting of regimen-related toxicity and
the prevention of recurrent leukemia. Over the past 10 years, considerable clinical
research has been devoted to the reduction of regimen-related toxicity through the use of
reduced-intensity (nonmyeloablative) transplants. However, leukemic relapse has remained a
difficult obstacle. Thus, the need for highly effective, yet non-toxic regimens persists,
particularly for elderly patients for whom very little overall progress has been made.
Clofarabine is a chemotherapeutic agent with novel myelotoxic properties and proven low
toxicity in older patients. These qualities suggest clofarabine may be a useful component
of conditioning regimens for stem cell transplantation.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival at one and two year
At 1 year and 2 Year
No
Edward Agura, MD
Principal Investigator
Baylor Health Care System
United States: Institutional Review Board
006-150
NCT00852163
March 2007
December 2011
Name | Location |
---|---|
Baylor University Medical Center | Dallas, Texas 75246 |