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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00715208
Other study ID # C05012
Secondary ID
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


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
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