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A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell

Thank you

Trial Information

A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Previously untreated CD20-positive diffuse large B-cell lymphoma

- Ann Arbour Stage III/IV and bulky II (mass >10 cm)

- At least one bi-dimensionally measurable lesion defined as >1.5 cm in its largest
dimension by CT scan

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

- Left ventricular ejection fraction >/= 50%

- Adequate hematologic function

Exclusion Criteria:

- Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or
immunotherapy

- Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local
irradiation

- CNS lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma,
primary effusion lymphoma

- Patients who received cytotoxic drugs or rituximab as part of their treatment for
another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody

- Chemotherapy or other investigational therapy within 28 days prior to the start of
Cycle 1

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

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

- History of other malignancy, except for curatively treated basal or squamous cell
carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy
treated with or without curative intent and in remission without treatment for >/=2
years prior to enrolment

- Positive for hepatitis B, hepatitis C, HIV or HTLV-1 infection

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response (CR), tumor assessments according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007)

Outcome Time Frame:

approximately 5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GAO4915g

NCT ID:

NCT01414855

Start Date:

August 2011

Completion Date:

October 2016

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Denver, Colorado  
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Las Vegas, Nevada  89109
Coeur D'alene, Idaho  83814