Relapsed Follicular Lymphoma Clinical Trial
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.
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Auxilio Cancer Center | Hato Rey | |
United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Medical Oncology, LLC | Baton Rouge | Louisiana |
United States | Providence Saint Joseph Medical Center | Burbank | California |
United States | Gabrail Cancer Center | Canton | Ohio |
United States | Southern Illinois Hematology Oncology | Centralia | Illinois |
United States | St. Louis Cancer Care, LLP | Chesterfield | Missouri |
United States | Alexian Brothers Hospital Network | Elk Grove Village | Illinois |
United States | San Juan Oncology Associates | Farmington | New Mexico |
United States | Pacific Coast Hematology Oncology Medical Group | Fountain Valley | California |
United States | Marshall University | Huntington | West Virginia |
United States | Hutchinson Clinic | Hutchinson | Kansas |
United States | Jackson Oncology Associates, PLLC | Jackson | Mississippi |
United States | Kalamazoo Hematology and Oncology | Kalamazoo | Michigan |
United States | University of Tennessee Medical Center | Knoxville | Tennessee |
United States | Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Nebraska Hematology-Oncology, PC | Lincoln | Nebraska |
United States | Loma Linda U Cancer Center | Loma Linda | California |
United States | Northwest Georgia Oncology Centers, PC | Marietta | Georgia |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | West Virginia University Health Science Center | Morgantown | West Virginia |
United States | Northwest Alabama Center, PC | Muscle Shoals | Alabama |
United States | Cancer Care Center, Inc. | New Albany | Indiana |
United States | NYU Clinical Cancer Center | New York | New York |
United States | Great Plains Regional Medical Center | North Platte | Nebraska |
United States | Ocala Cancer Institute | Ocala | Florida |
United States | Northern Utah Associates | Ogden | Utah |
United States | Oklahoma Oncology and Hematology, PC | Oklahoma City | Oklahoma |
United States | Purchase Cancer Group | Paducah | Kentucky |
United States | Temple University | Philadelphia | Pennsylvania |
United States | Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania |
United States | Desert Hematology Medical Group, Inc. | Rancho Mirage | California |
United States | HOPE Oncology | Richardson | Texas |
United States | Interlakes Foundation | Rochester | New York |
United States | Siouxland Hematology Oncology Associates | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Clintell, Inc. | Skokie | Illinois |
United States | Cancer Center of Central Connecticut | Southington | Connecticut |
United States | Oklahoma Oncology and Hematology, PC | Tulsa | Oklahoma |
United States | New York Medical College | Valhalla | New York |
United States | Landmark Medical Center | Woonsocket | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Millennium Pharmaceuticals, Inc. |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Complete Response (CR) | 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. | 30 weeks | No |
Secondary | Number of Participants With Overall Response (OR) | 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. |
30 weeks | No |
Secondary | Percentage of Participants With Progression-free Survival (PFS) at 1 Year | 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). | 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 | No |
Secondary | Duration of Response | 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. |
2 years | No |
Secondary | 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 | Yes |
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