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

Primary Purpose

Leukemia, T-Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
forodesine hydrochloride (BCX-1777)
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, T-Cell focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weil Medical College of Cornell University

Outcomes

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

Full Information

First Posted
November 3, 2004
Last Updated
January 18, 2012
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00095381
Brief Title
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, T-Cell
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride (BCX-1777)
Primary Outcome Measure Information:
Title
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary Outcome Measure Information:
Title
Safety and tolerability
Title
Pharmacokinetics (PK) and Pharmacodynamics (PD)
Title
maintenance of response and safety in long-term treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Weil Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
City
Tbilisi
ZIP/Postal Code
GE-380079
Country
Georgia

12. IPD Sharing Statement

Learn more about this trial

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

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