- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100711
Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
May 7, 2014 updated by: Pharmacyclics LLC.
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Refractory or Relapsed Disease
The primary purpose of this study is to determine if motexafin gadolinium may be an effective treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Secondly, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated.
Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment
27
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
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Minnesota
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Rochester, Minnesota, United States, 55905
- The Mayo Clinic
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Ohio
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Columbus, Ohio, United States, 43210-1240
- The Ohio State University
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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
- CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following: 1) Refractory disease- progressive disease while on therapy, or 2) Relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
- ECOG performance status score of 0, 1, or 2
- Willing and able to provide written informed consent
Exclusion Criteria:
Laboratory Values of:
- Platelet count < 30,000/µL
- AST or ALT > 2 x ULN (upper limit of normal)
- Total bilirubin > 2 x ULN
- Creatinine > 2.0 mg/dL
and
- Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
- Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
- Uncontrolled hypertension
- Known history of porphyria (testing not required at screening)
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
- Known history of HIV infection (testing not required at screening)
- Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
- Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
- Physical or mental condition that makes patient unable to complete specified follow-up assessments
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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Complete and partial response rates
|
Secondary Outcome Measures
Outcome Measure |
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Progression-free survival
|
Safety and tolerability
|
Duration of response
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Evens, D.O., Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- Principal Investigator: Neil E. Kay, MD, Mayo Clinic
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 Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 4, 2005
First Submitted That Met QC Criteria
January 4, 2005
First Posted (Estimate)
January 5, 2005
Study Record Updates
Last Update Posted (Estimate)
May 23, 2014
Last Update Submitted That Met QC Criteria
May 7, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Antineoplastic Agents
- Photosensitizing Agents
- Dermatologic Agents
- Motexafin gadolinium
Other Study ID Numbers
- PCYC-0222
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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