Trial reportBlood2011
Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia.
Trial report in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.
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.
An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL
Phase III Randomized Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Early Stage CLL With High Risk of Early Disease Progression
Who cites it
43 citing papers in PubMed, 1 synthesis or guideline pooled it, 120 citations in OpenAlex.
- Rituximab, ofatumumab and other monoclonal anti-CD20 antibodies for chronic lymphocytic leukaemia.The Cochrane database of systematic reviews · 2012Pooled it
- Ofatumumab combined with chlorambucil for previously untreated chronic lymphocytic leukemia: a phase I/II, open-label study in Japan.International journal of hematology · 2017Trial
- Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy.Leukemia & lymphoma · 2017Trial
- Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial.Leukemia & lymphoma · 2016Trial
- Trial
- Induced resistance to ofatumumab-mediated cell clearance mechanisms, including complement-dependent cytotoxicity, in chronic lymphocytic leukemia.Journal of immunology (Baltimore, Md. : 1950) · 2014Trial
- Trial
- A phase I/II study of ofatumumab (GSK1841157) in Japanese and Korean patients with relapsed or refractory B-cell chronic lymphocytic leukemia.International journal of hematology · 2013Trial
- Review
- Treatment Approaches to Chronic Lymphocytic Leukemia With High-Risk Molecular Features.Frontiers in oncology · 2021Review
- Infectious Complications of Biological and Small Molecule Targeted Immunomodulatory Therapies.Clinical microbiology reviews · 2020Review
- Advances in targeted therapy for malignant lymphoma.Signal transduction and targeted therapy · 2020Review
- Anti-CD20 monoclonal antibodies: reviewing a revolution.Human vaccines & immunotherapeutics · 2018Article
- Current Treatment of Chronic Lymphocytic Leukemia.Current treatment options in oncology · 2017Review
- Ofatumumab plus chlorambucil as a first-line therapy in less fit patients with chronic lymphocytic leukemia: analysis of COMPLEMENT1 and other monoclonal antibodies association data.Therapeutic advances in hematology · 2016Review
- Chronic lymphocytic leukemia: a clinical review including Korean cohorts.The Korean journal of internal medicine · 2016Review
- New developments in the management of chronic lymphocytic leukemia: role of ofatumumab.OncoTargets and therapy · 2016Review
- Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response.Journal of cancer science & therapy · 2015Article
- Review
- Ofatumumab and its role as immunotherapy in chronic lymphocytic leukemia.Haematologica · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 11 institutions in 5 countries.
Funding
Abstract
We conducted an international phase 2 trial to evaluate 2 dose levels of ofatumumab, a human CD20 mAb, combined with fludarabine and cyclophosphamide (O-FC) as frontline therapy for chronic lymphocytic leukemia (CLL). Patients with active CLL were randomized to ofatumumab 500 mg (n = 31) or 1000 mg (n = 30) day 1, with fludarabine 25 mg/m(2) and cyclophosphamide 250 mg/m(2) days 2-4, course 1; days 1-3, courses 2-6; every 4 weeks for 6 courses. The first ofatumumab dose was 300 mg for both cohorts. The median age was 56 years; 13% of patients had a 17p deletion; 64% had β2-microglobulin > 3.5 mg/L. Based on the 1996 National Cancer Institute Working Group (NCI-WG) guidelines, the complete response (CR) rate as assessed by an independent review committee was 32% for the 500-mg and 50% for the 1000-mg cohort; the overall response (OR) rate was 77% and 73%, respectively. Based on univariable regression analyses, β2-microglobulin and the number of O-FC courses were significantly correlated (P < .05) with CR and OR rates and progression-free survival (PFS). The most frequent Common Terminology Criteria (CTC) grade 3-4 investigator-reported adverse events were neutropenia (48%), thrombocytopenia (15%), anemia (13%), and infection (8%). O-FC is active and safe in treatment-naive patients with CLL, including high-risk patients. This trial was registered at www.clinicaltrials.gov as NCT00410163.
Indexed as
Identifiers
What OpenQuestion holds
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.