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.
Inclusion Criteria:
- Male or female patient 18 years of age or older
- Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma.
Patients with transformed follicular lymphoma are eligible, provided there has
previously been pathologic documentation of follicular lymphoma.
- Documented relapse or progression following prior antineoplastic therapy
- At least 1 measurable tumor mass that is greater than 1. 5 cm in the long axis and
greater than 1. 0 cm in the short axis that has not been previously irradiated, or has
grown since previous irradiation
- No clinically significant evidence of active central nervous system lymphoma
- Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group
Oncology Group [ECOG] status ≤2)
Exclusion Criteria:
- Diagnosed or treated for a malignancy other than NHL within 2 years of first dose, or
who were previously diagnosed with a malignancy other than NHL and have any
radiographic or biochemical marker evidence of malignancy. Patients with prostate
cancer who were treated with definitive radiotherapy who have a serum
prostate-specific antigen <1 ng/mL are not excluded. Patients are not excluded if
they have had basal cell or squamous cell carcinoma of the skin that was completely
resected, or any in situ malignancy that was adequately treated.
- Received any of the following treatments or procedures outside of the specified
timeframes:
- Prior treatment with VELCADE
- Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2,
if assigned to Arm A (VELCADE-R-CAP)
- Antineoplastic (including unconjugated therapeutic antibodies and toxin
immunoconjugates), experimental, or radiation therapy within 3 weeks before Day
1 of Cycle 1
- Nitrosoureas within 6 weeks before Day 1 of Cycle 1
- Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
- Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or
prior allogeneic stem cell transplant at any time
- Major surgery within 2 weeks before Day 1 of Cycle 1
For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center, Phone: 1-866-835-2233, Email: medical@mlnm.com
Auxilio Cancer Center, Hato Rey 00919, Puerto Rico; Recruiting
Northwest Alabama Center, PC, Muscle Shoals, Alabama 35661, United States; Recruiting
Pacific Coast Hematology Oncology Medical Group, Fountain Valley, California 92708, United States; Recruiting
Providence Saint Joseph Medical Center, Burbank, California 91505, United States; Recruiting
Loma Linda U Cancer Center, Loma Linda, California 92354, United States; Recruiting
Desert Hematology Medical Group, Inc., Rancho Mirage, California 92270, United States; Recruiting
Cancer Center of Central Connecticut, Southington, Connecticut 06498, United States; Recruiting
Ocala Cancer Institute, Ocala, Florida 34471, United States; Recruiting
Northwest Georgia Oncology Centers, PC, Marietta, Georgia 30060, United States; Recruiting
Clintell, Inc., Skokie, Illinois 60077, United States; Recruiting
Alexian Brothers Hospital Network, Elk Grove Village, Illinois 60007, United States; Recruiting
Southern Illinois Hematology Oncology, Centralia, Illinois 62801, United States; Recruiting
Cancer Care Center, Inc., New Albany, Indiana 47150, United States; Recruiting
Siouxland Hematology Oncology Associates, Sioux City, Iowa 51101, United States; Recruiting
Hutchinson Clinic, Hutchinson, Kansas 67502, United States; Recruiting
Purchase Cancer Group, Paducah, Kentucky 42001, United States; Recruiting
Medical Oncology, LLC, Baton Rouge, Louisiana 70809, United States; Recruiting
St. Joseph Mercy Hospital, Ann Arbor, Michigan 48106, United States; Recruiting
Kalamazoo Hematology and Oncology, Kalamazoo, Michigan 49048, United States; Recruiting
Jackson Oncology Associates, PLLC, Jackson, Mississippi 39202, United States; Recruiting
St. Louis Cancer Care, LLP, Chesterfield, Missouri 63017, United States; Recruiting
Nebraska Hematology-Oncology, PC, Lincoln, Nebraska 68506, United States; Recruiting
Great Plains Regional Medical Center, North Platte, Nebraska 69101, United States; Recruiting
Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States; Recruiting
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
San Juan Oncology Associates, Farmington, New Mexico 87401, United States; Recruiting
New York Medical College, Valhalla, New York 10595, United States; Recruiting
NYU Clinical Cancer Center, New York, New York 10016, United States; Recruiting
Interlakes Foundation, Rochester, New York 14623, United States; Recruiting
Gabrail Cancer Center, Canton, Ohio 44718, United States; Recruiting
Oklahoma Oncology and Hematology, PC, Oklahoma City, Oklahoma 73112, United States; Recruiting
Oklahoma Oncology and Hematology, PC, Tulsa, Oklahoma 74136, United States; Recruiting
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Temple University, Philadelphia, Pennsylvania 19140, United States; Recruiting
Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Landmark Medical Center, Woonsocket, Rhode Island 02895, United States; Recruiting
Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States; Recruiting
University of Tennessee Medical Center, Knoxville, Tennessee 37920, United States; Recruiting
HOPE Oncology, Richardson, Texas 75080, United States; Recruiting
Northern Utah Associates, Ogden, Utah 84403, United States; Recruiting
Marshall University, Huntington, West Virginia 25701, United States; Recruiting
West Virginia University Health Science Center, Morgantown, West Virginia 26505, United States; Recruiting
Marshfield Clinic, Marshfield, Wisconsin 54449, United States; Recruiting
