Skip to main content
OpenTrials
Completed

NCT Number: NCT00095381

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia, T-Cell Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tbilisi, Georgia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

forodesine hydrochloride (BCX-1777)

Drug

Primary outcomes

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

Secondary outcomes

  1. Safety and tolerability

  2. Pharmacokinetics (PK) and Pharmacodynamics (PD)

  3. maintenance of response and safety in long-term treatment

Sponsors and collaborators

Lead sponsor

BioCryst Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 4, 2004
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.