| Phase II Study of BCX-1777 in Patients With Recurrent or Refractory Advanced T-Cell Leukemia or Lymphoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information
Alternate Title
BCX-1777 in Treating Patients With Recurrent or Refractory Advanced T-Cell Leukemia or T-Cell Lymphoma
Basic Trial Information
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Phase II
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Treatment
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Active
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Any age
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BIOCRYST-BCX1777-T-04-201
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Objectives Primary - Determine the sustained effectiveness of BCX-1777 (by peripheral blood evaluation and confirmatory bone marrow evaluation) in patients with recurrent or refractory advanced T-cell leukemia or lymphoma.
Secondary - Determine the safety and tolerability of multiple courses of this drug in these patients.
- Determine the effect of this drug on plasma levels of 2'-deoxyguanosine (dGuo) and red blood cell purine nucleoside phosphorylase (PNP) activity in these patients.
- Correlate the plasma levels of dGuo and PNP with efficacy parameters of this drug in these patients.
- Determine the steady-state pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the maintenance of response to and safety of this drug given as long-term therapy in these patients.
Entry Criteria Disease Characteristics:
- Diagnosis of T-cell leukemia of one of the following types:
- T-cell acute lymphoblastic leukemia
- T-cell prolymphocytic leukemia
- T-cell lymphoma with circulating blasts
- No cutaneous T-cell lymphoma (including Sezary syndrome)
- Failed prior therapy OR relapsed after initial response to prior therapy
- No infrequent subsets of T-cell leukemia or natural killer leukemia (including large granular lymphocyte)
- No rapidly progressing disease with life-threatening, compensated organ function
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - More than 7 days since prior chemotherapy unless full recovery has occurred
Endocrine therapy - Concurrent corticosteroids allowed provided the dose is stable during study treatment
Radiotherapy Surgery Other - More than 7 days since prior investigational antileukemic agents unless full recovery has occurred
- No other concurrent anticancer agents
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic - AST and/or ALT ≤ 3 times upper limit of normal
Renal - Creatinine clearance > 50 mL/min
Other - No active serious infection uncontrolled by oral or IV antibiotics
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Projected Accrual A total of 20-30 patients will be accrued for this study. Outline This is an open-label, multicenter study. Patients receive BCX-1777 IV over 30 minutes once daily on days 1-5. Treatment repeats every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinically significant response may continue to receive BCX-1777 once daily on days 1 and 4. Treatment repeats every 7 days for 6 courses. Disclaimer The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations BioCryst Pharmaceuticals, Inc. | | | | BioCryst Team - BBCI, Traci Kruckemyer | | | |
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