Trial reportHaematologica2015
Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a phase IV, non-interventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia.
Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
18 citing papers in PubMed, 40 citations in OpenAlex.
- Case report: Identification of Hepatitis B Virus in the cerebrospinal fluid of neuromyelitis optica spectrum disorders and successful treatment with ofatumumab and inebilizumab.Frontiers in immunology · 2024Article
- Old and New Drugs for Chronic Lymphocytic Leukemia: Lights and Shadows of Real-World Evidence.Journal of clinical medicine · 2022Review
- Revolution of Chronic Lymphocytic Leukemia Therapy: the Chemo-Free Treatment Paradigm.Current oncology reports · 2020Review
- Hepatitis B Virus Reactivation: Risk Factors and Current Management Strategies.Pharmacotherapy · 2019Review
- From Biology to Therapy: The CLL Success Story.HemaSphere · 2019Review
- Experience with ibrutinib for first-line use in patients with chronic lymphocytic leukemia.Therapeutic advances in hematology · 2018Review
- Pharmacotherapy of relapsed/refractory chronic lymphocytic leukemia.Expert opinion on pharmacotherapy · 2017Review
- Optimizing antiviral agents for hepatitis B management in malignant lymphomas.Annals of translational medicine · 2017Review
- New Pharmacotherapies in Chronic Lymphocytic Leukemia.P & T : a peer-reviewed journal for formulary management · 2017Article
- Current Treatment of Chronic Lymphocytic Leukemia.Current treatment options in oncology · 2017Review
- Article
- Drug-associated progressive multifocal leukoencephalopathy: a clinical, radiological, and cerebrospinal fluid analysis of 326 cases.Journal of neurology · 2016Article
- Hepatitis B Reactivation with Novel Agents in Non-Hodgkin's Lymphoma and Prevention Strategies.Journal of clinical and translational hepatology · 2016Review
- Drugs under preclinical and clinical study for treatment of acute and chronic lymphoblastic leukemia.Patient preference and adherence · 2016Review
- New developments in the management of chronic lymphocytic leukemia: role of ofatumumab.OncoTargets and therapy · 2016Review
- Ofatumumab and its role as immunotherapy in chronic lymphocytic leukemia.Haematologica · 2015Article
- Natural Killer Cell-Based Therapies Targeting Cancer: Possible Strategies to Gain and Sustain Anti-Tumor Activity.Frontiers in immunology · 2015Review
- Clinical utility and patient considerations in the use of ofatumumab in chronic lymphocytic leukemia.Biologics : targets & therapy · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
35 authors at 20 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We report the largest retrospective, phase IV non-interventional, observational study of ofatumumab therapy in heavily pre-treated patients with poor-prognosis chronic lymphocytic leukemia. Total number of patients was 103; median age was 65 years (range 39-85). Median number of prior lines of therapy was 4 (range 1-13), including, in most cases, rituximab-, fludarabine- and alemtuzumab-based regimens; 13 patients had been allografted. Of 113 adverse events, 28 (29%) were considered to be directly related to ofatumumab. Grade 3-4 toxicities included neutropenia (10%), thrombocytopenia (5%), anemia (3%), pneumonia (17%), and fever (3%). Two heavily pre-treated patients developed progressive multifocal leukoencephalopathy. On an intention-to-treat analysis, the overall response rate was 22% (3 complete response, 1 incomplete complete response). Median progression-free and overall survival times were 5 and 11 months, respectively. This study confirms in a daily-life setting the feasibility and acceptable toxicity of ofatumumab treatment in advanced chronic lymphocytic leukemia. The complete response rate, however, was low. Therefore, treatment with ofatumumab should be moved to earlier phases of the disease. Ideally, this should be done in combination with other agents, as recently approved for ofatumumab plus chlorambucil as front-line treatment for patients unfit for fludarabine. This study is registered at clinicaltrials.gov identifier:01453062.
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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.