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An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma


Inclusion Criteria:



- History of histologically documented, CD20+, indolent NHL

- Refractory to any previous regimen containing rituximab

- Previously treated with a maximum of four unique chemotherapy containing treatment
regimens

- All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in
its largest dimension by CT scan)

Exclusion Criteria:

- Prior use of any monoclonal antibody (other than anti-CD20) within 3 months

- Chemotherapy or other investigational therapy within 28 days

- Prior treatment with bendamustine (within 2 years of the start of study treatment).
Patients with prior bendamustine treatment (greater than 2 years prior to the start
of study treatment ) are eligible if they meet both of the following criteria:
achieved either partial or complete response to the bendamustine regimen of at least
12 months in duration prior to relapse/progression and experienced progression
following a regimen containing an alkylating agent

- Prior allogeneic stem cell transplant

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
(e.g., patients in whom re-dosing with rituximab would be contraindicated for safety
reasons)

- History of sensitivity to mannitol

- Central nervous system lymphoma or histological evidence of transformation to high
grade or diffuse large B-cell lymphoma

- History of other malignancy that could affect compliance with the protocol or
interpretation of results

- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) or any major episode of infection
requiring treatment with intravenous antibiotics or hospitalization within 4 weeks

- Vaccination with a live vaccine a minimum of 28 days prior to randomization

- Recent major surgery (within 4 weeks), other than for diagnosis

- Presence of positive test results for Hepatitis B or Hepatitis C

- Known history of HIV seropositive status

- Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic
countries

- Women who are pregnant or lactating

- Agreement to use an effective form of contraception for the duration of the study

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

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 (PFS)

Outcome Time Frame:

Time from randomization to first occurrence of progression or relapse, or death

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GAO4753g

NCT ID:

NCT01059630

Start Date:

April 2010

Completion Date:

March 2018

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • follicular
  • follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Little Rock, Arkansas  72205-7199
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Eugene, Oregon  
Milwaukee, Wisconsin  
Washington, District of Columbia  
Sioux Falls, South Dakota