TriangleNCT01332968 · CITED IN SOURCE DOCUMENTS
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)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2022-08-11
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Overall Response (Overall Study Population), Investigator-Assessed
Complete Response (Follicular Lymphoma Population), Investigator-Assessed
Complete Response (Overall Study Population), Investigator-Assessed
Overall Response (Follicular Lymphoma Population), IRC-Assessed
Overall Response (Overall Study Population), IRC-Assessed
Complete Response (Follicular Lymphoma Population), IRC-Assessed
Complete Response (Overall Study Population), IRC-Assessed
Overall Survival (Follicular Lymphoma Population)
Overall Survival (Overall Study Population)
Event-Free Survival (Follicular Lymphoma Population)
Event-Free Survival (Overall Study Population)
Disease-Free Survival (Follicular Lymphoma Population)
Disease-Free Survival (Overall Study Population)
Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
Time to Next Anti-Lymphoma Treatment (Overall Study Population)
Percentage of Participants With Adverse Events
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
- intervention Names
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Bendamustine
- Drug: Rituximab
- label
- Rituximab+Chemotherapy
- type
- ACTIVE_COMPARATOR
- description
- Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
- intervention Names
- Drug: Obinutuzumab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Bendamustine
- label
- Obinutuzumab+Chemotherapy
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Obinutuzumab+Chemotherapy
- description
- Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.
- name
- Obinutuzumab
- other Names
- GA101; RO5072759
- type
- DRUG
- arm Group Labels
- Obinutuzumab+Chemotherapy
- Rituximab+Chemotherapy
- description
- Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
- name
- Cyclophosphamide
- type
- DRUG
- arm Group Labels
- Obinutuzumab+Chemotherapy
- Rituximab+Chemotherapy
- description
- Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
- name
- Doxorubicin
- type
- DRUG
- arm Group Labels
- Obinutuzumab+Chemotherapy
- Rituximab+Chemotherapy
- description
- Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
- name
- Vincristine
- type
- DRUG
- arm Group Labels
- Obinutuzumab+Chemotherapy
- Rituximab+Chemotherapy
- description
- Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
- name
- Prednisone
- type
- DRUG
- arm Group Labels
- Obinutuzumab+Chemotherapy
- Rituximab+Chemotherapy
- description
- Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
- name
- Bendamustine
- type
- DRUG
- arm Group Labels
- Rituximab+Chemotherapy
- description
- Rituximab 375 milligrams per square meter (mg/m\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\^2 every 2 months during maintenance period.
- name
- Rituximab
- other Names
- MabThera/Rituxan
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1401
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
- measure
- Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
- time Frame
- Baseline up to data cut-off (up to approximately 4 years and 7 months)
- secondary Outcomes
- description
- Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
- measure
- Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
- time Frame
- Baseline up to final analysis (up to 10 years)
- description
- Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI.
- measure
- Progression-Free Survival in the Overall Study Population, Investigator-Assessed
- time Frame
- Baseline up to data cut-off (up to approximately 5 years and 2 months)
- description
- Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.
- measure
- Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
- time Frame
- Baseline up to data cut-off (up to approximately 5 years and 2 months)
- description
- Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI.
- measure
- Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
- time Frame
- Baseline up to data cut-off (up to approximately 5 years and 2 months)
- description
- Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Overall Response (OR) = CR + PR.
- measure
- Overall Response (Follicular Lymphoma Population), Investigator-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%; Overall Response (OR) = CR + PR.
- measure
- Overall Response (Overall Study Population), Investigator-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
- measure
- Complete Response (Follicular Lymphoma Population), Investigator-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
- measure
- Complete Response (Overall Study Population), Investigator-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Overall Response (OR) = CR + PR.
- measure
- Overall Response (Follicular Lymphoma Population), IRC-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%; Overall Response (OR) = CR + PR.
- measure
- Overall Response (Overall Study Population), IRC-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
- measure
- Complete Response (Follicular Lymphoma Population), IRC-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- description
- Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
- measure
- Complete Response (Overall Study Population), IRC-Assessed
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)]
Full study description
- brief 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.
Source references
- references
- citation
- Jorgensen JB, Hansen KV, Nielsen LK, Gade IL, Pedersen MA, Jensen P, Simonsen MR, Knapp A, Gormsen LC, El-Galaly TC. First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a post hoc analysis of 472 patients in long-term remissions from the GALLIUM study. Leuk Lymphoma. 2026 May;67(6):1352-1361. doi: 10.1080/10428194.2026.2642931. Epub 2026 Mar 25.
- pmid
- 41879719
- type
- DERIVED
- citation
- Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, Hoster E. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. J Clin Oncol. 2024 Feb 10;42(5):550-561. doi: 10.1200/JCO.23.00838. Epub 2023 Dec 14.
- pmid
- 38096461
- type
- DERIVED
- citation
- Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.
- pmid
- 36379880
- type
- DERIVED
- citation
- Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. 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. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.
- pmid
- 35194005
- type
- DERIVED
- citation
- Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.
- pmid
- 34323957
- type
- DERIVED
- citation
- Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.
- pmid
- 32314038
- type
- DERIVED
- citation
- Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.
- pmid
- 31053601
- type
- DERIVED
- citation
- Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.
- pmid
- 30341058
- type
- DERIVED
- citation
- Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8.
- pmid
- 30309758
- type
- DERIVED
- citation
- Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.
- pmid
- 29856692
- type
- DERIVED
- citation
- Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.
- pmid
- 28976863
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-6ad24fc8b9df461587b1
- requested nct id
- NCT01332968
- primary nct id
- NCT01332968
- source kind
- fda_spl_label
- source record id
- 47afa519-4a05-4ac2-8604-437371837128
- source file sha256
- d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
- payload sha256
- fbdff1ed71bb557b4745da4724bd7550ef7a63f6d8cd62ddbdaf2b8f105f2fff
- payload
- application numbers
- BLA125486
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-6ad24fc8b9df461587b1
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT01332968
- occurrences
- context exact
- ed in Figure 4 . Figure 4 Kaplan-Meier Curve of Overall Survival in Patients with FL Figure 3 Figure 4 GALLIUM The efficacy of GAZYVA was evaluated in GALLIUM (NCT01332968), a multicenter, open-label, randomized study that included 1202 patients with previously untreated, stage II bulky, III or IV FL. Patients were randomized 1:1
- end
- 9478
- exact text
- NCT01332968
- start
- 9467
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00200.json
- source file sha256
- d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
- source json pointer
- /results/74/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 47afa519-4a05-4ac2-8604-437371837128
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- d7e1a0b4197426a523809c266f525692c61d16a0e723eedeaa72b95b36ed6c58
- spl effective time
- 20251219
- spl set id
- df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-ae4268664fa1ade092de
- requested nct id
- NCT01332968
- primary nct id
- NCT01332968
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- fac27ab868761312e338cd8f54adc7127cc23ca36a0da8e2b6602af150db8ee1
- payload sha256
- 9f134f3bcc18d0e1d8cfb8d2020800fd0666fc672f4551d2895090648c4c0979
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-ae4268664fa1ade092de
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT01332968
- occurrences
- context exact
- 1" tabindex="-1">Evidence (obinutuzumab):</p> <div class="pdq-content-list"><ol id="_1692"><li>A prospective randomized trial (<a href="/clinicaltrials/NCT01332968">NCT01332968</a>) of 1,202 patients with previously untreated follicular lymphoma compared obinutuzumab combined with bendamustine (50%), CHOP (cyclophosphamid
- end
- 243443
- exact text
- NCT01332968
- start
- 243432
- context exact
- -1">Evidence (obinutuzumab):</p> <div class="pdq-content-list"><ol id="_1692"><li>A prospective randomized trial (<a href="/clinicaltrials/NCT01332968">NCT01332968</a>) of 1,202 patients with previously untreated follicular lymphoma compared obinutuzumab combined with bendamustine (50%), CHOP (cyclophosphamide, doxorubici
- end
- 243456
- exact text
- NCT01332968
- start
- 243445
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/5301169da6885e1905.html
- source file sha256
- fac27ab868761312e338cd8f54adc7127cc23ca36a0da8e2b6602af150db8ee1
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:22:02.877411+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 047fe9b01d453b31f39642c6f8ce6a5b55b9a51535081307cd23fe3f476ba79f
- source title
- Indolent B-Cell Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: May 14, 2025
- datetime
- 2025-05-14T12:00:00Z
- display
- May 14, 2025
Preserved source evidence · Independent clinical review pending · Not medical advice