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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


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, T-Cell

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)

Authority:

United States: Food and Drug Administration

Study ID:

BCX1777-T-04-201

NCT ID:

NCT00095381

Start Date:

March 2004

Completion Date:

December 2007

Related Keywords:

  • Leukemia, T-Cell
  • 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
  • Leukemia
  • Leukemia, T-Cell

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Austin, Texas  78705
Flint, Michigan  48532
McLean, Virginia  22101
Kansas City, Kansas  66160
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Denver, Colorado  
Charleston, South Carolina  
Weil Medical College of Cornell University New York, New York  10021