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A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.


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

Thank you

Trial Information

A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic,
nodal or extranodal marginal zone lymphoma)

- Stage III or IV disease, or Stage II bulky disease (defined as tumour diameter >/= 7
cm), requiring treatment

- For patients with follicular lymphoma: requirement for treatment according to GELF
criteria

- For patients with symptomatic marginal zone lymphoma: disease that is de novo or has
relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy
as assessed by the investigator

- At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT
scan or MRI)

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

- Adequate hematologic function

Exclusion Criteria:

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

- Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's
macroglobulinaemia

- Ann Arbor Stage I disease

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy,
known hypersensitivity to any of the study drugs or sensitivity to murine products,
or history of sensitivity to mannitol

- For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma
with chemotherapy, immunotherapy, or radiotherapy

- For patients with non-follicular lymphoma: prior treatment with chemotherapy or
immunotherapy

- Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle
1

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

- For patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram

- History of prior malignancy with the exception of curatively treated basal or
squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix

- Known active infection, or major episode of infection within 4 week prior to the
start of Cycle 1

- Vaccination with a live vaccine within 28 days prior to randomization

- Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for
diagnosis

- Abnormal laboratory values as defined by protocol for creatinine, creatinine
clearance, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities
are due to underlying lymphoma

- Positive as per protocol definition for HIV, HTLV1, hepatitis C or chronic hepatitis
B

- Pregnant or lactating women

- Life expectancy < 12 months

- Participation in another clinical trial with drug intervention within 28 days prior
to start of Cycle 1 and during study

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 in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma

Outcome Time Frame:

up to approximately 7.5 years

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:

BO21223

NCT ID:

NCT01332968

Start Date:

July 2011

Completion Date:

March 2022

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Great Falls, Montana  59405
Fountain Valley, California  92708
Columbia, Missouri  65203
Seattle, Washington  98195
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Albuquerque, New Mexico  87131-5636
Eugene, Oregon  
Coeur D'alene, Idaho  83814