Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study
Phase: PHASE2
Conditions: Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
Sponsor: West Virginia University

NCT01203020
Once daily intravenous Busulf ex as part of reduced-toxicity conditioning for 
patients with relapsed/refractory Hodgkin's and non-Hodgkin's lymphomas 
undergoing allogeneic hematopoietic progenitor cell transplantation - A 
multicenter phase II study. 
11Oct2013

Protocol WVU 11310 
Version Date: Amendment 711OCT2013 
Schema 
Once daily intravenous Busulf ex as part of reduced-toxicity 
conditioning for patients with relapsed/refractory Hodgkin's 
and non-Hodgkin's lymphomas undergoing allogeneic 
hematopoietic progenitor cell transplantation - A 
multicenter phase II study. 
PRIMARY OBJECTIVES: 
1.
To assess 1-year PFS of patients with chemotherapy refractory Hodgkin and NHL
undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex
and fludarabine.
SECONDARY OBJECTIVES: 
1.
To record 1 and 2 year overall survival following transplantation.
2.
To record 2 year PFS.
3.
To assess NRM following RTC transplantation at day+ 100 and 1-year.
4.
To assess relapse rate following transplantation at day+ 100 and 1-year.
5.
To assess disease response rate following transplantation at day+ 100 and at 1-year.
6.
To correlate OS, PFS, RR, NRM following HSCT with systemic busulfan exposure.
7.
To assess rates of acute and chronic GVHD.
8.
Time to successful neutrophil engraftment.
9.
Time to successful platelet engraftment.
10. To assess rates of primary and secondary graft failure.
11. To assess rates of primary and secondary graft rejection.
12. To assess rates of pulmonary toxicity and VOD post transplantation, and assess
correlation with Busulfex exposure levels.
13. To assess lineage specific chimerism kinetics of donor cells following once daily IV
Busulfex based RTC at days +30, +100, +180 and +365.
14. To correlate chimerism kinetics following transplantation with Busulfex exposure levels.
15. To determine immune reconstitution pattern at days +30, + 100, + 180, and +365.
16. To evaluate biologic & genetic markers associated with the malignancy, GVHD and/or
the treatment.
STUDY DESIGN: 
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) 
following reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in 
patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas. 
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