Phase 3
Completed N=1,401
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)
Source: ClinicalTrials.gov NCT01332968 ↗Enrolled (actual)
1,401
Serious AEs
48.2%
Results posted
Jun 2017
Primary outcomePrimary: Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed — 24.0; 16.8 percentage of participants with event — p=0.0012
◆ Published Evidence
Established
32citations · ~16 / year
Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study.
Summary
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.
Linked Publications (5)
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Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study.
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Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study.
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Single-nucleotide Fcγ receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma.
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Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study.
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First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a <i>post hoc</i> analysis of 472 patients in long-term remissions from the GALLIUM study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed |
40.6; 34.3 | 0.0055 sig |
| SECONDARY Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed |
40.6; 34.3 | 0.0055 sig |
| SECONDARY Progression-Free Survival in the Overall Study Population, Investigator-Assessed |
41.5; 34.8 | 0.0028 sig |
| SECONDARY Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed |
23.5; 18.0 | 0.0118 sig |
| SECONDARY Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) |
24.6; 18.4 | 0.0038 sig |
| SECONDARY Overall Response (Follicular Lymphoma Population), Investigator-Assessed |
86.4; 88.2; 81.2; 85.5 | 0.30 |
| SECONDARY Overall Response (Overall Study Population), Investigator-Assessed |
85.7; 87.3; 81.8; 85.4 | 0.33 |
| SECONDARY Complete Response (Follicular Lymphoma Population), Investigator-Assessed |
24.1; 18.6; 56.7; 62.0 | 0.02 sig |
| SECONDARY Complete Response (Overall Study Population), Investigator-Assessed |
23.3; 18.4; 57.0; 61.1 | 0.02 sig |
| SECONDARY Overall Response (Follicular Lymphoma Population), IRC-Assessed |
88.0; 91.3; 85.2; 88.6 | 0.052 |
| SECONDARY Overall Response (Overall Study Population), IRC-Assessed |
86.7; 89.9; 83.3; 87.2 | 0.049 sig |
| SECONDARY Complete Response (Follicular Lymphoma Population), IRC-Assessed |
26.8; 28.5; 59.7; 71.4 | 0.58 |
| SECONDARY Complete Response (Overall Study Population), IRC-Assessed |
26.3; 27.1; 59.4; 69.5 | 0.80 |
| SECONDARY Overall Survival (Follicular Lymphoma Population) |
14.3; 12.6 | 0.3577 |
| SECONDARY Overall Survival (Overall Study Population) |
10.2; 8.4 | 0.25 |
| SECONDARY Event-Free Survival (Follicular Lymphoma Population) |
42.9; 35.8 | 0.0015 sig |
| SECONDARY Event-Free Survival (Overall Study Population) |
30.6; 22.6 | 0.0004 sig |
| SECONDARY Disease-Free Survival (Follicular Lymphoma Population) |
27.9; 26.3 | — |
| SECONDARY Disease-Free Survival (Overall Study Population) |
14.9; 11.2 | — |
| SECONDARY Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed |
39.3; 33.3 | — |
| SECONDARY Duration of Response (DOR) (Overall Study Population), Investigator-Assessed |
25.5; 18.7 | — |
| SECONDARY Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) |
34.8; 26.6 | 0.001 sig |
| SECONDARY Time to Next Anti-Lymphoma Treatment (Overall Study Population) |
21.6; 15.7 | 0.004 sig |
| SECONDARY Percentage of Participants With Adverse Events |
99.6; 99.9 | — |
| SECONDARY Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) |
23.36; 23.14; -0.91; -0.21; -0.06; 0.56 | — |
| SECONDARY Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) |
86.61; 86.94; 0.46; 2.18; 2.91; 4.57 | — |
| SECONDARY Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) |
45.01; 45.54; 2.04; 2.71; 2.99; 3.01 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) |
127.40; 128.42; 1.98; 3.21; 4.18; 5.10 | — |
| SECONDARY Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase |
0.80; 0.81; 0.03; 0.03; 0.04; 0.03 | — |
| SECONDARY Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase |
0.04; 0.04; 0.06; 0.06; 0.03; 0.05 | — |
| SECONDARY Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase |
0.05; 0.06; 0.05; 0.06 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01332968) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.