NCT00076401

Brief Summary

The purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come back after treatment or that has stopped responding to treatment.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 21, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2004

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

First QC Date

January 21, 2004

Last Update Submit

June 25, 2014

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic

Keywords

CLLchronic lymphocytic leukemiarelapsed chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaLeukemiaMotexafin gadoliniumChronic leukemiaLymphocytic leukemia, chronic

Interventions

Motexafin gadoliniumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old
  • Refractory or relapsed CLL
  • ECOG performance status score of 0, 1, or 2
  • Each patient must sign a study-specific informed consent form

You may not qualify if:

  • Laboratory values of:
  • Platelet count \<30,000/uL
  • AST or ALT \>2 x the upper limit of normal (ULN)
  • Total bilirubin \>2 x ULN
  • Creatinine \>2.0 mg/dL
  • Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy within 21 days before beginning study treatment
  • Women who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2004

First Posted

January 26, 2004

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

US(1)