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Brief Title: Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Official Title: A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.
Study ID: NCT00715208
Brief Summary: This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northwest Alabama Center, PC, Muscle Shoals, Alabama, United States
Providence Saint Joseph Medical Center, Burbank, California, United States
Pacific Coast Hematology Oncology Medical Group, Fountain Valley, California, United States
Loma Linda U Cancer Center, Loma Linda, California, United States
Desert Hematology Medical Group, Inc., Rancho Mirage, California, United States
Cancer Center of Central Connecticut, Southington, Connecticut, United States
Ocala Cancer Institute, Ocala, Florida, United States
Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States
Southern Illinois Hematology Oncology, Centralia, Illinois, United States
Alexian Brothers Hospital Network, Elk Grove Village, Illinois, United States
Clintell, Inc., Skokie, Illinois, United States
Cancer Care Center, Inc., New Albany, Indiana, United States
Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States
Hutchinson Clinic, Hutchinson, Kansas, United States
Purchase Cancer Group, Paducah, Kentucky, United States
Medical Oncology, LLC, Baton Rouge, Louisiana, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Kalamazoo Hematology and Oncology, Kalamazoo, Michigan, United States
Jackson Oncology Associates, PLLC, Jackson, Mississippi, United States
St. Louis Cancer Care, LLP, Chesterfield, Missouri, United States
Nebraska Hematology-Oncology, PC, Lincoln, Nebraska, United States
Great Plains Regional Medical Center, North Platte, Nebraska, United States
Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
NYU Clinical Cancer Center, New York, New York, United States
Interlakes Foundation, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Oklahoma Oncology and Hematology, PC, Oklahoma City, Oklahoma, United States
Oklahoma Oncology and Hematology, PC, Tulsa, Oklahoma, United States
Temple University, Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, United States
Landmark Medical Center, Woonsocket, Rhode Island, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
HOPE Oncology, Richardson, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Marshall University, Huntington, West Virginia, United States
West Virginia University Health Science Center, Morgantown, West Virginia, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Auxilio Cancer Center, Hato Rey, , Puerto Rico
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR