Clinical Trial: Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase IIb, Multicenter, Open-Label, Nonrandomized, Repeat-Dose Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/
Brief Summary: The purpose of this study is to determine whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens.
Detailed Summary:
Sponsor: BioCryst Pharmaceuticals
Current Primary Outcome: To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine the rate of CR achieved based on prior HSCT status
- Assess safety and tolerability
- Assess survival end points
- Evaluate the maintenance and duration of response
- Evaluate the proportion of patients able to proceed to HSCT
- Evaluate the effects of this forodesine regimen on plasma levels of dGuo
- Determine the effects of this forodesine regimen on clinical end points
- Explore potential predictive biomarkers
Original Secondary Outcome: Same as current
Information By: BioCryst Pharmaceuticals
Dates:
Date Received: January 5, 2007
Date Started: July 2006
Date Completion:
Last Updated: January 18, 2012
Last Verified: January 2012