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A Phase III, Multicenter, Open-label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell

Thank you

Trial Information

A Phase III, Multicenter, Open-label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)

- At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the
CT scan)

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Adequate hematological function

- Low-intermediate, intermediate or high-risk IPI score (low-risk IPI score: IPI 1
irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion >/=
7.5 cm)

Exclusion Criteria:

- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies or known sensitivity or allergy to murine products

- Contraindication to any of the individual components of CHOP, including prior receipt
of anthracyclines

- Patients with transformed lymphoma and patients with follicular lymphoma IIIB

- Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation

- Prior treatment with cytotoxic drugs or rituximab for another condition (e.g.,
rheumatoid arthritis) or prior use of an anti-CD20 antibody

- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1

- Ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent

- Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence
of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion
lymphoma, and primary cutaneous DLBCL

- Positive for HIV

- Active hepatitis B or C infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival, assessed by the investigator according to a modified version of the Revised Response Criteria for Malignant Lymphoma

Outcome Time Frame:

up to approximately 78 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO21005

NCT ID:

NCT01287741

Start Date:

July 2011

Completion Date:

November 2016

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Scarborough, Maine  04074
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon  
Charleston, South Carolina