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)

Completed · Phase 3

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT01332968

Run by

Hoffmann-La Roche

People needed

1401

Starts

2011-07-06

Expected to finish

2021-07-30

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Regents of the University of California; Office of Research — Irvine, California, United States
• Kootenai Cancer Center — Post Falls, Idaho, United States
• Illinois Cancer Care, P.C. - Galesburg — Galesburg, Illinois, United States
• Siouxland Hematology/Oncology — Sioux City, Iowa, United States
• University of Kansas; Medical Center & Medical pavilion — Westwood, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Mercy Medical Research Institute — Springfield, Missouri, United States
• MT Cancer Inst Fndtn; MT Can Spec — Missoula, Montana, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Northwest Medical Specialties — Tacoma, Washington, United States
• Concord Repatriation General Hospital; Haematology — Sydney, New South Wales, Australia
• Westmead Hospital; Haematology — Sydney, New South Wales, Australia
• Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology — Woolloongabba, Queensland, Australia
• St Vincent'S Hospital; Haematology — Fitzroy, Victoria, Australia
• Peter MacCallum Cancer Centre; Department of Haematology — Melbourne, Victoria, Australia
• Austin and Repatriation Medical Centre; Cancer Services — Melbourne, Victoria, Australia
• Monash Medical Centre; Haematology — Melbourne, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• UZ Gent — Ghent, Belgium
• AZ Groeninge — Kortrijk, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Tom Baker Cancer Centre-Calgary — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Highlands Oncology Group — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.