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

Primary Purpose

Relapsed Follicular Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin
VELCADE
prednisone
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwest Alabama Center, PC
  • Providence Saint Joseph Medical Center
  • Pacific Coast Hematology Oncology Medical Group
  • Loma Linda U Cancer Center
  • Desert Hematology Medical Group, Inc.
  • Cancer Center of Central Connecticut
  • Ocala Cancer Institute
  • Northwest Georgia Oncology Centers, PC
  • Southern Illinois Hematology Oncology
  • Alexian Brothers Hospital Network
  • Clintell, Inc.
  • Cancer Care Center, Inc.
  • Siouxland Hematology Oncology Associates
  • Hutchinson Clinic
  • Purchase Cancer Group
  • Medical Oncology, LLC
  • St. Joseph Mercy Hospital
  • Kalamazoo Hematology and Oncology
  • Jackson Oncology Associates, PLLC
  • St. Louis Cancer Care, LLP
  • Nebraska Hematology-Oncology, PC
  • Great Plains Regional Medical Center
  • Southern Nevada Cancer Research Foundation
  • Dartmouth Hitchcock Medical Center
  • San Juan Oncology Associates
  • NYU Clinical Cancer Center
  • Interlakes Foundation
  • New York Medical College
  • Gabrail Cancer Center
  • Oklahoma Oncology and Hematology, PC
  • Oklahoma Oncology and Hematology, PC
  • Temple University
  • Allegheny-Singer Research Institute
  • Western Pennsylvania Cancer Institute
  • Landmark Medical Center
  • Avera Cancer Institute
  • University of Tennessee Medical Center
  • HOPE Oncology
  • Northern Utah Associates
  • Marshall University
  • West Virginia University Health Science Center
  • Marshfield Clinic
  • Auxilio Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

VELCADE R-CAP

VELCADE R-CP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
Number of Patients Who Experienced at Least One Serious Adverse Event

Full Information

First Posted
July 11, 2008
Last Updated
April 26, 2013
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00715208
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Follicular Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VELCADE R-CAP
Arm Type
Experimental
Arm Description
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.
Arm Title
VELCADE R-CP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Type
Drug
Intervention Name(s)
VELCADE
Intervention Type
Drug
Intervention Name(s)
prednisone
Primary Outcome Measure Information:
Title
Number of Patients With Complete Response (CR)
Description
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.
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Overall Response (OR)
Description
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.
Time Frame
30 weeks
Title
Percentage of Participants With Progression-free Survival (PFS) at 1 Year
Description
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).
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
Title
Duration of Response
Description
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.
Time Frame
2 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Alabama Center, PC
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Providence Saint Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Pacific Coast Hematology Oncology Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Loma Linda U Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Desert Hematology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06498
Country
United States
Facility Name
Ocala Cancer Institute
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Southern Illinois Hematology Oncology
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Alexian Brothers Hospital Network
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Clintell, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Cancer Care Center, Inc.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Siouxland Hematology Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Hutchinson Clinic
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Purchase Cancer Group
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Medical Oncology, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Kalamazoo Hematology and Oncology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
St. Louis Cancer Care, LLP
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Nebraska Hematology-Oncology, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Great Plains Regional Medical Center
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Interlakes Foundation
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oklahoma Oncology and Hematology, PC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oklahoma Oncology and Hematology, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny-Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Western Pennsylvania Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Landmark Medical Center
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
HOPE Oncology
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Marshall University
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
West Virginia University Health Science Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Auxilio Cancer Center
City
Hato Rey
ZIP/Postal Code
00919
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25039282
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.
Results Reference
derived

Learn more about this trial

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

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