Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715208
• Other study ID #: C05012
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2008
• Last updated: April 26, 2013
• Start date: September 2008
• Est. completion date: March 2011

Study information

• Verified date: April 2013
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Relapsed Follicular Lymphoma

Intervention

Drug:
• rituximab

• cyclophosphamide

• doxorubicin

• VELCADE

• prednisone

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

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