Trial reportHaematologica2016
Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma.
Trial report in Haematologica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 36 citations in OpenAlex.
- Obinutuzumab as consolidation after chemo-immunotherapy: Results of the UK National Cancer Research Institute phase II/III GALACTIC trial.British journal of haematology · 2022Trial
- Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study.British journal of clinical pharmacology · 2019Trial
- Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first-line immunochemotherapy.British journal of clinical pharmacology · 2019Trial
- Safety, tolerability and pharmacokinetics of shorter duration of infusion of obinutuzumab in Japanese patients with B-cell non-Hodgkin lymphoma: final results of the phase II GATS study.Japanese journal of clinical oncology · 2018Trial
- Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Single-Agent and Associated Therapies with Monoclonal Antibodies: What About Follicular Lymphoma?Cancers · 2025Review
- Harnessing the Immune System: An Effective Way to Manage Diffuse Large B-Cell Lymphoma.Journal of hematology · 2023Review
- Rituximab versus obinutuzumab-based first-line chemoimmunotherapy for follicular lymphoma-a real-world multicenter retrospective cohort study.Annals of hematology · 2023Article
- Clinical Pharmacokinetic and Pharmacodynamic Considerations in Treating Non-Hodgkin Lymphoma.Clinical pharmacokinetics · 2020Review
- Anti-CD20 Directed Therapy of B Cell Lymphomas: Are New Agents Really Better?Current oncology reports · 2018Review
- Review of targeted therapy in chronic lymphocytic leukemia: what a radiologist needs to know about CT interpretation.Cancer imaging : the official publication of the International Cancer Imaging Society · 2018Review
- Strategies for clinical development of monoclonal antibodies beyond first-in-human trials: tested doses and rationale for dose selection.British journal of cancer · 2018Article
- Dual-Color Bioluminescent Sensor Proteins for Therapeutic Drug Monitoring of Antitumor Antibodies.Analytical chemistry · 2018Article
- Anti-CD20 monoclonal antibodies: reviewing a revolution.Human vaccines & immunotherapeutics · 2018Article
- Pharmacokinetics of obinutuzumab in Chinese patients with B-cell lymphomas.British journal of clinical pharmacology · 2017Article
- Obinutuzumab: A Review in Rituximab-Refractory or -Relapsed Follicular Lymphoma.Targeted oncology · 2017Review
- A Review of Obinutuzumab (GA101), a Novel Type II Anti-CD20 Monoclonal Antibody, for the Treatment of Patients with B-Cell Malignancies.Advances in therapy · 2017Review
- Impact of obinutuzumab alone and in combination for follicular lymphoma.Blood and lymphatic cancer : targets and therapy · 2017Review
- The clinical development of obinutuzumab for the treatment of follicular lymphoma.Cancer management and research · 2017Review
- Obinutuzumab in chronic lymphocytic leukemia: design, development and place in therapy.Drug design, development and therapy · 2017Review
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Obinutuzumab (GA101) is a type II, glycoengineered anti-CD20 monoclonal antibody for the treatment of hematologic malignancies. Obinutuzumab has mechanisms of action that are distinct from those of rituximab, potentially translating into improved clinical efficacy. We present the pharmacokinetic and clinical data from the phase I/II GAUGUIN and phase I GAUDI studies that were used to identify the obinutuzumab dose and regimen undergoing phase III assessment. In phase I (GAUGUIN and GAUDI), non-Hodgkin lymphoma patients received up to a maximum 9 fixed doses (obinutuzumab 50-2000 mg). In GAUGUIN phase II, patients received obinutuzumab 400/400 mg or 1600/800 mg [first dose day (D)1, D8, cycle (C) 1; second dose D1, C2-C8]. The influence of demographic factors on pharmacokinetics and drug exposure on tumor response and toxicity were analyzed using exploratory graphical analyses. Obinutuzumab serum concentrations with 1600/800 mg were compared with a 1000 mg fixed-dose regimen (D1, D8 and D15, C1; D1, C2-C8) using pharmacokinetic modeling simulations. Factors related to CD20-antigenic mass were more influential on obinutuzumab pharmacokinetics with 400/400 versus 1600/800 mg. Higher serum concentrations were observed with 1600/800 versus 400/400 mg, irrespective of CD20-antigenic mass. Tumor shrinkage was greater with 1600/800 versus 400/400 mg; there was no significant increase in adverse events. Fixed dose 1000 mg with an additional C1 infusion resulted in similar serum concentrations to 1600/800 mg in model-based analyses. The obinutuzumab 1000 mg fixed-dose regimen identified in this exploratory analysis was confirmed in a full covariate analysis of a larger dataset, and is undergoing phase III evaluation. GAUGUIN and GAUDI are registered at www.clinicaltrials.gov (clinicaltrials.gov identifier:00517530 and 00825149, respectively).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.