ArticleBlood2015
Obinutuzumab plus fludarabine/cyclophosphamide or bendamustine in the initial therapy of CLL patients: the phase 1b GALTON trial.
Article in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01300247 (An Open-Label, Multicenter, Phase Ib Trial of GA101), which is not on this map. Cited by 38 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.
An Open-Label, Multicenter, Phase Ib Trial of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Who cites it
38 citing papers in PubMed, 73 citations in OpenAlex.
- Trial
- Pretreatment with ibrutinib reduces cytokine secretion and limits the risk of obinutuzumab-induced infusion-related reactions in patients with CLL: analysis from the iLLUMINATE study.Annals of hematology · 2021Trial
- Trial
- Safety of obinutuzumab alone or combined with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia in the phase IIIb GREEN study.Haematologica · 2018Trial
- Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study.Leukemia · 2018Trial
- Cyclic Fasting-Mimicking Diet Plus Bortezomib and Rituximab Is an Effective Treatment for Chronic Lymphocytic Leukemia.Cancer research · 2024Article
- Obinutuzumab in the treatment of B-cell malignancies: a comprehensive review.Future oncology (London, England) · 2022Review
- New and Old Anti-CD20 Monoclonal Antibodies for Nephrotic Syndrome. Where We Are?Frontiers in immunology · 2022Review
- Venetoclax plus bendamustine-rituximab or bendamustine-obinutuzumab in chronic lymphocytic leukemia: final results of a phase 1b study (GO28440).Haematologica · 2021Article
- Article
- Time-limited, Combined Regimen in Chronic Lymphocytic Leukemia: A Promising Strategy to Achieve a Drug Holiday.Current medical science · 2021Review
- Ibrutinib reduces obinutuzumab infusion-related reactions in patients with chronic lymphocytic leukemia and is associated with changes in plasma cytokine levels.Haematologica · 2020Article
- Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.Oncoimmunology · 2020Review
- Article
- Clinical application of obinutuzumab for treating chronic lymphocytic leukemia.Drug design, development and therapy · 2019Review
- Emerging treatment options for patients with p53-pathway-deficient CLL.Therapeutic advances in hematology · 2019Review
- BENDAMUSTINE: AN OLD DRUG IN THE NEW ERA FOR PATIENTS WITH NON-HODGKIN LYMPHOMAS AND CHRONIC LYMPHOCYTIC LEUKEMIA.Acta clinica Croatica · 2018Review
- Frontline Therapy of CLL: Evolving Treatment Paradigm.Current hematologic malignancy reports · 2018Review
- The Role of Rituximab in Chronic Lymphocytic Leukemia Treatment and the Potential Utility of Biosimilars.The oncologist · 2018Review
- Anti-CD20 monoclonal antibodies: reviewing a revolution.Human vaccines & immunotherapeutics · 2018Article
Corrections and comments
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Authors and funding
8 authors at 6 institutions in 1 country.
Funding
Abstract
Obinutuzumab is a type 2, glycoengineered, anti-CD20 antibody recently approved with chlorambucil for the initial therapy of chronic lymphocytic leukemia (CLL). In this nonrandomized, parallel-cohort, phase 1b, multicenter study, we explored the safety and preliminary efficacy of obinutuzumab-bendamustine (G-B) or obinutuzumab fludarabine cyclophosphamide (G-FC) for the therapy of previously untreated fit patients with CLL. Patients received up to 6 cycles of G-B (n = 20) or G-FC (n = 21). The primary end point was safety, with infusion-related reactions (88%, grade 3-4 20%) being the most common adverse event and grade 3-4 neutropenia in 55% on G-B and 48% on G-FC. Mean cycles completed were 5.7 for G-B and 5.1 for G-FC, with 2 and 7 early discontinuations, respectively. The objective response rate (ORR) for G-B was 90% (18/20) with 20% complete response (CR) and 25% CR with incomplete marrow recovery (CRi). The ORR for G-FC was 62% (13/21), with 10% CR and 14% CRi, including 4 patients not evaluable. With a median follow-up of 23.5 months in the G-B cohort and 20.7 months in the G-FC cohort, no patient has relapsed or died. We conclude that obinutuzumab with either B or FC shows manageable toxicity and has promising activity. This study was registered at www.clinicaltrials.gov as #NCT01300247.
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Registered trials
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.