Leukemia, T-Cell
Conditions
Keywords
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
Brief summary
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
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.
Interventions
Sponsors
BioCryst Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
| Pharmacokinetics (PK) and Pharmacodynamics (PD) | — |
| maintenance of response and safety in long-term treatment | — |
Countries
Georgia, United States
Outcome results
None listed