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A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma


Inclusion Criteria:



Subjects must satisfy the following criteria to be enrolled in the study:

- Man or woman and age 18 years or older

- Diagnosis of follicular B-NHL of the following subtypes (World Health Organization
[WHO] classification 1997): follicular lymphoma (FL) (Grades 1 and 2).

- Documented relapse or progression following prior antineoplastic treatment. New
lesions or objective evidence of progression of existing lesions must document
relapse or progression following the previous therapy.

If any prior regimen included rituximab, the subject must have responded (complete
response [CR], unconfirmed complete response [CRu], partial response [PR]), and the time
to progression (TTP) from the first dose of rituximab must have been 6 months or more.

- At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and
greater than 1.0 cm in the short axis) that has not been previously irradiated, or
has grown since previous irradiation

- In the opinion of the investigator the decision to initiate treatment is justified to
manage the subject's lymphoma

- No active central nervous system lymphoma

- Eastern Cooperative Oncology Group [ECOG] status ≤ 2

- Female subjects must be postmenopausal (for at least 6 months), surgically sterile,
abstinent, or, if sexually active, be practicing an effective method of birth control
(e.g., prescription oral contraceptives, contraceptive injections, intrauterine
device, double-barrier method, contraceptive patch, male partner sterilization)
before entry and throughout the study; and have a negative serum beta-human chorionic
gonadotropin (β-hCG) pregnancy test at screening.

- Subjects (or their legally acceptable representatives) must have signed an informed
consent document indicating that they understand the purpose of and procedures
required for the study and are willing to participate in the study.

- In countries where health authorities have approved the pharmacogenomic testing,
subjects or their legally acceptable representatives must have signed a separate
informed consent that they agree to participate in the genetic part and protein
testing part of the study; participation in the genetic and protein testing component
is mandatory for pharmacogenomics testing, but optional for serum protein testing and
future testing.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from
participating in the study:

- Diagnosed or treated for a malignancy other than NHL within 1 year of randomization,
or who were previously diagnosed with a malignancy other than NHL and have any
radiographic or biochemical marker evidence of malignancy. Subjects with completely
resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ
malignancy are not excluded.

- Clinical evidence of a transformation from indolent NHL to a more aggressive form of
NHL.

- History of disallowed therapies:

- Prior treatment with VELCADE

- Antineoplastic (including unconjugated therapeutic antibodies), experimental, or
radiation therapy within 3 weeks before randomization

- Nitrosoureas within 6 weeks before randomization

- Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before
randomization

- Stem cell transplant within 6 months before randomization

- Major surgery within 2 weeks before randomization

- Residual toxic effects of previous therapy or surgery of Grade 3 or worse

- Peripheral neuropathy or neuropathic pain of Grade 2 or worse

- Have received an experimental drug or used an experimental medical device within 21
days before the planned start of treatment.

- History of allergic reaction attributable to compounds containing boron or mannitol

- Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine
proteins or to any component of rituximab including polysorbate 80 and sodium citrate
dihydrate

- Concurrent treatment with another investigational agent

- Female subject who is pregnant or breast-feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Description:

Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.

Outcome Time Frame:

Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

26866138-LYM-3001

NCT ID:

NCT00312845

Start Date:

March 2006

Completion Date:

July 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • B-cell Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
South Texas Oncology and HematologySan Antonio, Texas  78229
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Oncology ConsultantsHouston, Texas  77024
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pacific Shores Medical GroupLong Beach, California  90813
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Vanderbilt UniversityNashville, Tennessee  37232-6305
Oregon Health & Science UniversityPortland, Oregon  97201
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
South Carolina Oncology AssociatesColumbia, South Carolina  29201
The Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Sinai HospitalBaltimore, Maryland  21215
University of California, Los AngelesLos Angeles, California  
East Alabama Medical CenterOpelika, Alabama  36801-5452
Ventura County Hematology-Oncology SpecialistsOxnard, California  93030
Cancer Care Associates Medical Group, Inc.Torrance, California  90505
Louisville OncologyLouisville, Kentucky  40202
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Suburban Hematology-Oncology AssociatesLawrenceville, Georgia  30045
University of Southern CaliforniaLos Angeles, California  90033
Hematology & Oncology SpecialistsNew Orleans, Louisiana  70115
University of California, Irvine Medical CenterOrange, California  92868
Norwalk Medical GroupNorwalk, Connecticut  06856
Hematology Oncology PCStamford, Connecticut  06902
Investigative Clinical Research of IndianaIndianapolis, Indiana  46254
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Kansas City Cancer Center, LLCOverland Park, Kansas  66210
Central Hematology Oncology Medical Group, IncAlhambra, California  91801
St. Jude Heritage Medical GroupFullerton, California  92835
North Valley Hematology OncologyMission Hills, California  91345
Innovative Clinical Research of South FloridaMiami, Florida  
Emory Univeersity ,Winship Cancer InstituteAtlanta, Georgia  
Siouxland Hematolgoy-Oncology AssociatesSioux City, Iowa  
Hattiesburg ClinicHattesburg, Missouri  
Lancaster Cancer Center, Ltd.Lancaster, Pennsylvania  17601
Medical College of Wisconsin MilwaukeeMilwaukee, Wisconsin