Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas
|ClinicalTrials.gov Identifier: NCT00035022|
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : January 13, 2006
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphocytic Lymphoma||Drug: BCX-1777||Phase 1 Phase 2|
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)|
|Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Completion Date :||March 2004|
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|
|Principal Investigator:||Deborah A. Thomas, M.D.||M.D. Anderson Cancer Center|