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A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

Primary Purpose

Leukemia, Leukemia, Lymphocytic, Chronic

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motexafin gadolinium
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring CLL, chronic lymphocytic leukemia, relapsed chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, Leukemia, Motexafin gadolinium, Chronic leukemia, Lymphocytic leukemia, chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Ohio State University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 21, 2004
Last Updated
June 25, 2014
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00076401
Brief Title
A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)
Official Title
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Leukemia, Lymphocytic, Chronic
Keywords
CLL, chronic lymphocytic leukemia, relapsed chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, Leukemia, Motexafin gadolinium, Chronic leukemia, Lymphocytic leukemia, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Motexafin gadolinium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

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