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

April 26, 2013 updated by: Millennium Pharmaceuticals, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: cyclophosphamide
Drug: prednisone
Drug: rituximab
Drug: doxorubicin
Drug: VELCADE
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.
Drug: cyclophosphamide
Drug: prednisone
Drug: rituximab
Drug: VELCADE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Complete Response (CR)
Time Frame: 30 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Overall Response (OR)
Time Frame: 30 weeks

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
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
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
Duration of Response
Time Frame: 2 years

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
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
From completion of informed consent through 30 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 26, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C05012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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