Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
- Conditions
- Relapsed Follicular Lymphoma
- Interventions
- Registration Number
- NCT00715208
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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)
-
Diagnosed or treated for a malignancy other than Non-Hodgkin's Lymphoma (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VELCADE R-CAP VELCADE VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CP VELCADE VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CAP rituximab VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CAP cyclophosphamide VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CAP doxorubicin VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CAP prednisone VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CP cyclophosphamide VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CP rituximab VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. VELCADE R-CP prednisone VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
- Primary Outcome Measures
Name Time Method Number of Patients With Complete Response (CR) 30 weeks Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.
- Secondary Outcome Measures
Name Time Method Number of Participants With Overall Response (OR) 30 weeks OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.
CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET.Percentage of Participants With Progression-free Survival (PFS) at 1 Year Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).
Duration of Response 2 years Time (in months) from the first documentation of a response (CR or partial response \[PR\]) to the date of first documentation of progressive disease or relapse from complete response.
CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria.Number of Patients Who Experienced at Least One Serious Adverse Event From completion of informed consent through 30 days after the last dose of study drug
Trial Locations
- Locations (42)
Loma Linda U Cancer Center
🇺🇸Loma Linda, California, United States
Oklahoma Oncology and Hematology, PC
🇺🇸Tulsa, Oklahoma, United States
Desert Hematology Medical Group, Inc.
🇺🇸Rancho Mirage, California, United States
Kalamazoo Hematology and Oncology
🇺🇸Kalamazoo, Michigan, United States
Nebraska Hematology-Oncology, PC
🇺🇸Lincoln, Nebraska, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
New York Medical College
🇺🇸Valhalla, New York, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Marshall University
🇺🇸Huntington, West Virginia, United States
Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
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
Cancer Care Center, Inc.
🇺🇸New Albany, Indiana, United States
Northwest Georgia Oncology Centers, PC
🇺🇸Marietta, Georgia, United States
Alexian Brothers Hospital Network
🇺🇸Elk Grove Village, Illinois, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Cancer Center of Central Connecticut
🇺🇸Southington, Connecticut, United States
Southern Illinois Hematology Oncology
🇺🇸Centralia, Illinois, United States
Clintell, Inc.
🇺🇸Skokie, Illinois, United States
Ocala Cancer Institute
🇺🇸Ocala, Florida, 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
Jackson Oncology Associates, PLLC
🇺🇸Jackson, Mississippi, United States
St. Louis Cancer Care, LLP
🇺🇸Chesterfield, Missouri, United States
Great Plains Regional Medical Center
🇺🇸North Platte, Nebraska, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Interlakes Foundation
🇺🇸Rochester, New York, United States
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Landmark Medical Center
🇺🇸Woonsocket, Rhode Island, United States
West Virginia University Health Science Center
🇺🇸Morgantown, West Virginia, United States
HOPE Oncology
🇺🇸Richardson, Texas, United States
Auxilio Cancer Center
🇵🇷Hato Rey, Puerto Rico
Northern Utah Associates
🇺🇸Ogden, Utah, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States