- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00086034
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma
May 11, 2007 updated by: Pharmacyclics LLC.
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL).
Secondly, the safety and side effects of motexafin gadolinium will be evaluated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92121
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Stanford, California, United States, 94305
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Florida
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Miami, Florida, United States, 33136
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Illinois
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Chicago, Illinois, United States, 60611
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Maryland
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Baltimore, Maryland, United States, 21231
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Minnesota
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Rochester, Minnesota, United States, 55905
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Wisconsin
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Madison, Wisconsin, United States, 53792
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 18 years old
- Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
- Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
- ECOG performance status score either 0 or 1
- Willing and able to provide written informed consent
Exclusion Criteria:
Laboratory values of:
- Platelet count < 50,000/µL
- AST or ALT > 2 x the upper limit of normal (ULN)
- Total bilirubin > 2 x ULN
- Creatinine > 2.0 mg/dL
and
- Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
- Uncontrolled hypertension
- Known history of porphyria, G6PD deficiency, HIV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical response rate
|
Secondary Outcome Measures
Outcome Measure |
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Progression-free survival
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Safety and tolerability
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Duration of clinical response
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brad Kahl, MD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 21, 2004
First Submitted That Met QC Criteria
June 22, 2004
First Posted (Estimate)
June 23, 2004
Study Record Updates
Last Update Posted (Estimate)
May 15, 2007
Last Update Submitted That Met QC Criteria
May 11, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCYC-0221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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