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