Clinical trial NCT00715208: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed Follicular Lymphoma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Complete Response (CR)
timeFrame: 30 weeks
Secondary outcomes:
measure: Number of Participants With Overall Response (OR)
timeFrame: 30 weeks
measure: Percentage of Participants With Progression-free Survival (PFS) at 1 Year
timeFrame: 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
measure: Duration of Response
timeFrame: 2 years
measure: Number of Patients Who Experienced at Least One Serious Adverse Event
timeFrame: From completion of informed consent through 30 days after the last dose of study drug
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Center, PC
state: Alabama
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology Oncology Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda U Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Medical Group, Inc.
state: California
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Ocala
country: United States
facility: Ocala Cancer Institute
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Centralia
country: United States
facility: Southern Illinois Hematology Oncology
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Skokie
country: United States
facility: Clintell, Inc.
state: Illinois
city: New Albany
country: United States
facility: Cancer Care Center, Inc.
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology Oncology Associates
state: Iowa
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
city: Paducah
country: United States
facility: Purchase Cancer Group
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Oncology, LLC
state: Louisiana
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology and Oncology
state: Michigan
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Chesterfield
country: United States
facility: St. Louis Cancer Care, LLP
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology, PC
state: Nebraska
city: North Platte
country: United States
facility: Great Plains Regional Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: Rochester
country: United States
facility: Interlakes Foundation
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Oncology and Hematology, PC
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Oncology and Hematology, PC
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Woonsocket
country: United States
facility: Landmark Medical Center
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Richardson
country: United States
facility: HOPE Oncology
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Huntington
country: United States
facility: Marshall University
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Health Science Center
state: West Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Hato Rey
country: Puerto Rico
facility: Auxilio Cancer Center
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Craig M, Hanna WT, Cabanillas F, Chen CS, Esseltine DL, Neuwirth R, O'Connor OA. Phase II study of bortezomib in combination with rituximab, cyclophosphamide and prednisone with or without doxorubicin followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma. Br J Haematol. 2014 Sep;166(6):920-8. doi: 10.1111/bjh.12991. Epub 2014 Jul 9.