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

Leukemia, T-Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095381
• Other study ID #: BCX1777-T-04-201
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2004
• Last updated: January 18, 2012
• Start date: March 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2012
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00086788

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, T-Cell

Intervention

Drug:
• forodesine hydrochloride (BCX-1777)

Locations

Country	Name	City	State
United States	Weil Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Countries where clinical trial is conducted

United States,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary	Safety and tolerability
Secondary	Pharmacokinetics (PK) and Pharmacodynamics (PD)
Secondary	maintenance of response and safety in long-term treatment