Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas
Completed · Phase 1/Phase 2
Conditions studied: Leukemia, Lymphocytic, Lymphoma
In brief
The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas.
Key facts
- Study ID
- NCT00035022
- Run by
- BioCryst Pharmaceuticals
- People needed
- 71
- Starts
- 2001-08-01
- Expected to finish
- 2004-03-01
- Last updated by the study team
- 2006-01-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- All ages are eligible. Pediatric patients (<15 years of age) are eligible to be treated at a dose level previously tested in adults.
- Adequate liver and renal function.
- Patients with prior history of stem cell transplant if they meet all other eligibility requirements.
- Negative pregnancy test within 72 hours of study treatment in females of childbearing potential.
- Life expectancy of at least 2 months.
- Exclusion:
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
- Concurrent treatment with other anti-cancer agents.
- Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. Lumbar puncture not required in asymptomatic patients.
- Pregnant and/or lactating women; or fertile men or women not willing to use contraception.
Where it is running
- M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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