Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pharmacyclics |
---|---|
Information provided by: | Pharmacyclics |
ClinicalTrials.gov Identifier: | NCT00290004 |
The primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. 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.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia Lymphoma |
Drug: motexafin gadolinium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Weekly Motexafin Gadolinium (MGd) for Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
Estimated Enrollment: | 35 |
Study Start Date: | November 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Laboratory values of:
United States, California | |
USC Norris Cancer Hospital | |
Los Angeles, California, United States, 90033 | |
Scripps Cancer Center | |
San Diego, California, United States, 92121 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Minnesota | |
The Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Andrew Evens, DO | Robert H Lurie Comprehensive Cancer Center of Northwestern University |
Principal Investigator: | Neil E Kay, MD | Mayo Clinic |
Study ID Numbers: | PCYC-0223 |
Study First Received: | February 8, 2006 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00290004 |
Health Authority: | United States: Food and Drug Administration |
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia Lymphoma Motexafin Gadolinium |
Relapsed Chronic Lymphocytic Leukemia Relapsed Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Small Lymphocytic Lymphoma |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Leukemia, B-cell, chronic Motexafin gadolinium Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |
Photosensitizing Agents Neoplasms Neoplasms by Histologic Type Radiation-Sensitizing Agents Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |