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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00095381
First received: November 3, 2004
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Leukemia, T-Cell
Drug: forodesine hydrochloride (BCX-1777)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

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

Secondary Outcome Measures:
  • Safety and tolerability
  • Pharmacokinetics (PK) and Pharmacodynamics (PD)
  • maintenance of response and safety in long-term treatment

Estimated Enrollment: 20
Study Start Date: March 2004
Study Completion Date: December 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095381

  Show 24 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
  More Information

No publications provided

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00095381     History of Changes
Obsolete Identifiers: NCT00086788
Other Study ID Numbers: BCX1777-T-04-201
Study First Received: November 3, 2004
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioCryst Pharmaceuticals:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, T-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014