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A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma

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Trial Information

A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma


Inclusion Criteria:



- Male or female subject 18 years or older

- Diagnosis of B-cell lymphoma (CD20+) of

- follicular lymphoma (grades 1, 2, and 3) or

- marginal zone lymphoma (extranodal, nodal, and splenic)

- Documented relapse or progression following prior anti-neoplastic treatment.

- At least 1 measurable lymph node mass that is >1.5 cm.

- No active CNS lymphoma

- Voluntary consent

Exclusion Criteria:

- Previous treatment with VELCADE

- Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of
study drug.

- Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.

- Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study
drug.

- Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before
the first dose of study drug.

- Radiation therapy within 3 weeks before the first dose of study drug.

- Major surgery within 2 weeks before the first dose of study drug.

- Peripheral neuropathy or neuropathic pain

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

- Known anaphylaxis or hypersensitivity to any component of rituximab

- Diagnosed or treated for a selected malignancies other than NHL within 5 years.

- Active systemic infection requiring treatment

- Female subjects must not be pregnant, breast-feeding, or become pregnant during the
course of the study.

- Male subjects who do not agree to use an acceptable method of contraception for the
duration of the study

- Any serious medical or psychiatric illness likely to interfere with participation in
this clinical study

- Concurrent treatment with another investigational agent. Concurrent participation in
non-treatment studies is allowed, if it will not interfere with participation in this
study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

M34103-061

NCT ID:

NCT00085696

Start Date:

May 2004

Completion Date:

Related Keywords:

  • B-Cell Lymphoma
  • Follicular Lymphoma
  • Marginal Lymphoma
  • Lymphoma
  • Non-Hodgkin's
  • NHL
  • B-Cell
  • Indolent
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
UCLA School of MedicineLos Angeles, California  900121973
Rush University Medical CenterChicago, Illinois  60612-3824
Georgia Cancer SpecialistsDecatur, Georgia  30033
Florida Cancer SpecialistsFort Myers, Florida  33901
Charleston Cancer CenterCharleston, South Carolina  29406
Midwest Cancer Research GroupSkokie, Illinois  60077
University of Utah, Huntsman Cancer InstituteSalt Lake City, Utah  84112
Emory University Cancer Institute, Winship Cancer InstituteAtlanta, Georgia  30322
Cancer Center of KansasWichita, Kansas  67214
Oncology/Henmatology Associates of Kansas CityKansas City, Missouri  64111
Mid Ohio Oncology/Hematology Inc.Columbus, Ohio  43213
FNVHO - US OncologyFairfax, Virginia  20031