Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT ID: NCT00290004
Last Updated: 2008-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2005-11-30
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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motexafin gadolinium
Eligibility Criteria
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Inclusion Criteria
* 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:
* Refractory disease: progressive disease while on therapy
* 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
* Platelet count \< 30,000/µL
* AST or ALT \> 2 x ULN (upper limit of normal)
* Total bilirubin \> 2 x ULN
* Creatinine \> 2 mg/dL
* Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (\> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
* Major surgery or hospitalization for a serious illness within the last 3 months
* Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
* Prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
* Uncontrolled hypertension
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Principal Investigators
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Andrew Evens, DO
Role: PRINCIPAL_INVESTIGATOR
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Neil E Kay, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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USC Norris Cancer Hospital
Los Angeles, California, United States
Scripps Cancer Center
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
The Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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PCYC-0223
Identifier Type: -
Identifier Source: org_study_id