Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
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|ClinicalTrials.gov Identifier: NCT00095381|
Recruitment Status : Completed
First Posted : November 4, 2004
Last Update Posted : January 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, T-Cell||Drug: forodesine hydrochloride (BCX-1777)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Masking:||None (Open Label)|
|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 Forodesine Hydrochloride (BCX-1777) Use|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||December 2007|
- Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
- Safety and tolerability
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- maintenance of response and safety in long-term treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095381
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