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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionRelapsed Follicular Lymphoma
InterventionDrug: rituximab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: VELCADE
Drug: prednisone
PhasePhase 2
SponsorMillennium Pharmaceuticals, Inc.
Responsible PartyMillennium Pharmaceuticals, Inc.
ClinicalTrials.gov IdentifierNCT00715208
First ReceivedJuly 11, 2008
Last UpdatedApril 26, 2013
Last verifiedApril 2013

Tracking Information[ + expand ][ + ]

First Received DateJuly 11, 2008
Last Updated DateApril 26, 2013
Start DateSeptember 2008
Estimated Primary Completion DateMarch 2011
Current Primary Outcome MeasuresNumber of Patients With Complete Response (CR) [Time Frame: 30 weeks] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Number of Participants With Overall Response (OR) [Time Frame: 30 weeks] [Designated as safety issue: No]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 [Time Frame: 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] [Designated as safety issue: No]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 [Time Frame: 2 years] [Designated as safety issue: No]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 [Time Frame: From completion of informed consent through 30 days after the last dose of study drug] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitlePhase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Official TitleA 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.
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionRelapsed Follicular Lymphoma
InterventionDrug: rituximab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: VELCADE
Drug: prednisone
Study Arm (s)
  • Experimental: VELCADE R-CAP
    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.
  • Experimental: VELCADE R-CP
    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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment55
Estimated Completion DateMarch 2011
Estimated Primary Completion DateFebruary 2011
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Puerto Rico

Administrative Information[ + expand ][ + ]

NCT Number NCT00715208
Other Study ID NumbersC05012
Has Data Monitoring CommitteeNot Provided
Information Provided ByMillennium Pharmaceuticals, Inc.
Study SponsorMillennium Pharmaceuticals, Inc.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Verification DateApril 2013

Locations[ + expand ][ + ]

Northwest Alabama Center, PC
Muscle Shoals, Alabama, United States, 35661
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Pacific Coast Hematology Oncology Medical Group
Fountain Valley, California, United States, 92708
Loma Linda U Cancer Center
Loma Linda, California, United States, 92354
Desert Hematology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06498
Ocala Cancer Institute
Ocala, Florida, United States, 34471
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
Southern Illinois Hematology Oncology
Centralia, Illinois, United States, 62801
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States, 60007
Clintell, Inc.
Skokie, Illinois, United States, 60077
Cancer Care Center, Inc.
New Albany, Indiana, United States, 47150
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Hutchinson Clinic
Hutchinson, Kansas, United States, 67502
Purchase Cancer Group
Paducah, Kentucky, United States, 42001
Medical Oncology, LLC
Baton Rouge, Louisiana, United States, 70809
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States, 49048
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
St. Louis Cancer Care, LLP
Chesterfield, Missouri, United States, 63017
Nebraska Hematology-Oncology, PC
Lincoln, Nebraska, United States, 68506
Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69101
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
NYU Clinical Cancer Center
New York, New York, United States, 10016
Interlakes Foundation
Rochester, New York, United States, 14623
New York Medical College
Valhalla, New York, United States, 10595
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Oklahoma Oncology and Hematology, PC
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Oncology and Hematology, PC
Tulsa, Oklahoma, United States, 74136
Temple University
Philadelphia, Pennsylvania, United States, 19140
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Landmark Medical Center
Woonsocket, Rhode Island, United States, 02895
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
HOPE Oncology
Richardson, Texas, United States, 75080
Northern Utah Associates
Ogden, Utah, United States, 84403
Marshall University
Huntington, West Virginia, United States, 25701
West Virginia University Health Science Center
Morgantown, West Virginia, United States, 26505
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Auxilio Cancer Center
Hato Rey, Puerto Rico, 00919