Clinical Trial: Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Foro
Brief Summary:
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.
Detailed Summary: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Sponsor: BioCryst Pharmaceuticals
Current Primary Outcome: Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- maintenance of response and safety in long-term treatment
Original Secondary Outcome: Same as current
Information By: BioCryst Pharmaceuticals
Dates:
Date Received: November 3, 2004
Date Started: March 2004
Date Completion:
Last Updated: January 18, 2012
Last Verified: January 2012
