NCT00035022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

January 13, 2006

Status Verified

February 1, 2005

First QC Date

May 2, 2002

Last Update Submit

January 12, 2006

Conditions

Leukemia, LymphocyticLymphoma

Keywords

Leukemia, Lymphoma, T-Cell

Interventions

BCX-1777DRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, LymphoidLymphomaLeukemia

Interventions

forodesine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Deborah A. Thomas, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

August 1, 2001

Study Completion

March 1, 2004

Last Updated

January 13, 2006

Record last verified: 2005-02

Locations

US(1)