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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 16, 2013