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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
Not Enrolling
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

- 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

- 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

- Concurrent treatment with another investigational agent

- Female subject who is pregnant or breast-feeding

Type of Study:


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:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




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



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