A Phase II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients with Advanced T-Cell Leukemia with an Option of Long-Term Forodesine Hydrochloride Use - N/A
- Conditions
- Advanced T-cell Leukaemia (either precursor T-Lymphoblastic Leukaemia/Lymphoma or T-cell Prolymphocytic Leukaemia [T-PLL]).MedDRA version: 7.0 Level: hlgt Classification code 10024324
- Registration Number
- EUCTR2004-004286-15-GB
- Lead Sponsor
- BioCryst Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
•Documented T-cell leukemia (percursor T-lymphoblastic leukaemia/lymphoma or T-cell prolymphocytic leukaemia [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 of normal)
•Adequate kidney function (calculated creatinine clearance >50 mL/min)
•Negative urine pregnancy test within 2 to 7 days prior to the start of study treatment 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 in such a manner that the risk of pregnancy is minimized
•Signed informed consent form prior to start of any study specific procedures
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients with known human immunodeficiency virus (HIV) infection or human T-cell
leukemia virus type 1 (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 antileukemic 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 a stable dose)
•Pregnant and/or lactating female
•Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method