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A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Diffuse Large B-Cell Lymphoma

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Trial Information

A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma


Inclusion Criteria:



- Male or female patients 18 years or older.

- Newly Diagnosed non-GCBsubtype of DLBCL (Stage II, III or IV).

- At least 1 measurable site of disease.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- 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
before entry and throughout the study; and have a negative pregnancy test at
screening.

- Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

- Prior treatment with VELCADE.

- Prior extended radiotherapy or chemotherapy for lymphoma

- More that 150 mg/m2 of prior doxorubicin

- Major surgery within 3 weeks of study.

- Peripheral neuropathy or neuralgia of Grade 2 or worse.

- Active CNS lymphoma

- Diagnosed or treated for a malignancy other than NHL, with some exceptions

- Pregnant or breast feeding

- Active systemic infection

- Documented of suspected human immunodeficiency virus (HIV)/AIDS

- Uncontrolled or severe cardiovascular disease

- Known allergies,hypersensitivity or intolerance to study drugs

- Serious medical condition that could interfere with study

- Concurrent treatment with another investigational agent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response (CR) rate

Outcome Time Frame:

18-24 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-2034

NCT ID:

NCT01040871

Start Date:

January 2010

Completion Date:

August 2012

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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