Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Leukemia, T-Cell

Intervention / Treatment
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* Drug: forodesine hydrochloride (BCX-1777)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL) Failure to have responded to one or more standard regimens for their disease. Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria All ages are eligible Life expectancy of at least 3 months Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits or normal [ULN]) Adequate kidney function (calculated creatinine clearance >50 mL/min) Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study Signed informed consent/assent form (ICF) prior to start of any study specific procedures Exclusion Criteria: Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1) Patients with known Hepatitis B and/or Hepatitis C active infection Patients with active CMV infection Tumor-related central nervous system (CNS) leukemia requiring active treatment Active serious infection not controlled by oral or IV antibiotics Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred. Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose) Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome) Pregnant and/or lactating women
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: forodesine hydrochloride (BCX-1777)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 
| Pharmacokinetics (PK) and Pharmacodynamics (PD) |  |  | 
| maintenance of response and safety in long-term treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Lymphocytic, T-Cell, Entry Term Lymphocytic Leukemia, T-Cell, T-Cell Leukemia, T-Lymphocytic Leukemia, Leukemia, Lymphocytic, T Cell, T Lymphocytic Leukemia, BCX-1777, forodesine hydrochloride, BioCryst