Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

Inclusion Criteria:

• 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.