Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation
Non-myeloablative conditioning allows curative allogeneic hematopoietic transplantation for
patients unable to tolerate more toxic conventional conditioning regiments. These regiments
continue to be refined and evolve. No standard regimen is yet agreed upon. The
incorporation of the newly licenses agent Clofarabine into a non-myeloablative regimen is
logical given its recognized anti-leukemic activity. This study will assess the safety and
efficacy of Cyclophosphamide and Clofarabine in promoting hematopoietic engraftment after
allogeneic transplant of blood stem cells. Patients eligibility will include those with
advanced hematological neoplasms who might benefit from allogeneic blood cell transplant.
Patients must have adequate organ function and suitable related or unrelated donors for
transplant. In Phase I of the study 9-12 patients will be treated in order to establish
Cyclophosphamide and Clofarabine dose, and to confirm reasonable safety and engraftment
efficacy. Phase II will treat at total of 20 patients at the selected dose level of
Clofarabine and Cyclophosphamide. Results will be compared to extensive Penn State Milton
S. Hershey Medical Center experience using Fludarabine and Cyclophosphamide in a similar
patient population. Supportive care, including graft versus host disease prophylaxis will
be similar to that recently used at Hershey Medical Center. Primary endpoints will include
survival and engraftment as compared to historical results at Hershey Medical Center.
Disease specific outcomes for frequent diagnoses such as acute leukemia and non-hodgkin's
lymphoma will be assessed as secondary endpoints.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment.
David F Claxton, MD
Penn State College of Medicine
United States: Institutional Review Board
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|