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

January 18, 2012 updated by: BioCryst Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia, GE-380079
  • United States
    • California
      • Los Angeles, California, United States, 90024
      • Palo Alto, California, United States, 94304
    • Colorado
      • Denver, Colorado, United States, 80262
    • Florida
      • Gainesville, Florida, United States, 32611
      • Lecanto, Florida, United States, 34461
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Missouri
      • Rolla, Missouri, United States, 65401
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • Bronx, New York, United States, 10467
      • New York, New York, United States, 10021
      • New York, New York, United States, 10021
        • Weil Medical College of Cornell University
      • Syracuse, New York, United States, 13210
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Austin, Texas, United States, 78701
      • Houston, Texas, United States, 77030
    • Virginia
      • Abingdon, Virginia, United States, 24211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Safety and tolerability
Pharmacokinetics (PK) and Pharmacodynamics (PD)
maintenance of response and safety in long-term treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 3, 2004

First Submitted That Met QC Criteria

November 3, 2004

First Posted (Estimate)

November 4, 2004

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX1777-T-04-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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