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

Primary Purpose

Leukemia, Lymphocytic, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BCX-1777
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

  • M.D. Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2002
Last Updated
January 12, 2006
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00035022
Brief Title
Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas
Official Title
Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BCX-1777

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A. Thomas, M.D.
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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