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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00035022
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : January 13, 2006
Information provided by:
BioCryst Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic Lymphoma Drug: BCX-1777 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
Study Start Date : August 2001
Estimated Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035022

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
BioCryst Pharmaceuticals
Principal Investigator: Deborah A. Thomas, M.D. M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT00035022     History of Changes
Obsolete Identifiers: NCT00066235
Other Study ID Numbers: BC-01-02
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: January 13, 2006
Last Verified: February 2005

Keywords provided by BioCryst Pharmaceuticals:
Leukemia, Lymphoma, T-Cell

Additional relevant MeSH terms:
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases