Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas

NCT ID: NCT00035022

Last Updated: 2006-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2004-03-31

Brief Summary

The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas.

Detailed Description

Despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.

The purpose of the phase I portion of the study is to determine the maximum tolerated dose (MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.

The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.

Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment.

Conditions

Leukemia, Lymphocytic; Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BCX-1777

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease.
• Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
• All ages are eligible. Pediatric patients (<15 years of age) are eligible to be treated at a dose level previously tested in adults.
• Adequate liver and renal function.
• Patients with prior history of stem cell transplant if they meet all other eligibility requirements.
• Negative pregnancy test within 72 hours of study treatment in females of childbearing potential.
• Life expectancy of at least 2 months.

Exclusion:

• Active serious infection not controlled by oral or intravenous antibiotics.
• Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
• Concurrent treatment with other anti-cancer agents.
• Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. Lumbar puncture not required in asymptomatic patients.
• Pregnant and/or lactating women; or fertile men or women not willing to use contraception.

• Minimum Eligible Age: 0 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Deborah A. Thomas, M.D.

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

BC-01-02

Identifier Type: -

Identifier Source: org_study_id

NCT00066235

Identifier Type: -

Identifier Source: nct_alias