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

Sponsor

BioCryst Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00035022

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Aug 1, 2001

Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M.D. Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

BioCryst Pharmaceuticals

Investigators

Principal Investigator: Deborah A. Thomas, M.D., M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00035022

Other Study ID Numbers:

BC-01-02
NCT00066235

First Posted:

May 3, 2002

Last Update Posted:

Jan 13, 2006

Last Verified:

Feb 1, 2005

Keywords provided by , ,

Leukemia, Lymphoma, T-Cell

Additional relevant MeSH terms:

Lymphoma

Leukemia

Leukemia, Lymphoid

Study Results

No Results Posted as of Jan 13, 2006