A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | July 6, 2011 |
End Date: | April 8, 2021 |
A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
This open-label, randomized study will assess the efficacy and safety of obinutuzumab
(RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with
chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated
advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants
achieving response (Complete response [CR] or partial response [PR]) will undergo a
maintenance period continuing on the randomized antibody treatment alone every 2 months until
disease progression for a total of 2 years. Anticipated time on study treatment is up to
approximately 2.5 years. After maintenance or observation, participants will be followed for
5 years until progression. After progression, participants will be followed for new
anti-lymphoma therapy and overall survival until the end of the study.
(RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with
chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated
advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants
achieving response (Complete response [CR] or partial response [PR]) will undergo a
maintenance period continuing on the randomized antibody treatment alone every 2 months until
disease progression for a total of 2 years. Anticipated time on study treatment is up to
approximately 2.5 years. After maintenance or observation, participants will be followed for
5 years until progression. After progression, participants will be followed for new
anti-lymphoma therapy and overall survival until the end of the study.
Inclusion Criteria:
- Cluster of differentiation 20 (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 tumor diameter greater
than or equal to [>/=] 7 centimeters [cm])
- For participants with follicular lymphoma: requirement for treatment according to
Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- For participants with symptomatic splenic, nodal, or non-gastric extranodal 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 (greater than [>] 2 cm in its largest
dimension by computed tomography [CT] scan or magnetic resonance imaging [MRI])
- Eastern Cooperative Oncology Group (ECOG) performance status of 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 participants with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma
with chemotherapy, immunotherapy, or radiotherapy
- For participants 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 participants who will be receiving cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP): left ventricular ejection fraction (LVEF) less than (<) 50% by
multiple-gated acquisition (MUGA) scan or echocardiogram
- History of prior other malignancy with the exception of curatively treated basal or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time
prior to study
- 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, aspartate transaminase (AST) or alanine transaminase (ALT), total
bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or
activated partial thromboplastin time (aPPT), unless these abnormalities are due to
underlying lymphoma
- Positive test results for human immunodeficiency virus (HIV), human T-lymphotropic
virus 1 (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
We found this trial at
13
sites
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141 Innovation Drive
Irvine, California 92697
Irvine, California 92697
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Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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2650 Shawnee Mission Parkway
Westwood, Kansas 66205
Westwood, Kansas 66205
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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