Trial reportLeukemia2014
Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial.
Trial report in Leukemia, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- The efficacy and safety of rituximab in treating childhood refractory nephrotic syndrome: a meta-analysis.Scientific reports · 2015Pooled it
- Trial
- Trial
- Taking the Next Step in Double Refractory Disease: Current and Future Treatment Strategies for Chronic Lymphocytic Leukemia.OncoTargets and therapy · 2024Review
- Immunotherapeutic Strategies in Chronic Lymphocytic Leukemia: Advances and Challenges.Frontiers in oncology · 2022Review
- Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.Frontiers in immunology · 2020Review
- Renal involvement in chronic lymphocytic leukemia.Clinical kidney journal · 2018Article
- BENDAMUSTINE: AN OLD DRUG IN THE NEW ERA FOR PATIENTS WITH NON-HODGKIN LYMPHOMAS AND CHRONIC LYMPHOCYTIC LEUKEMIA.Acta clinica Croatica · 2018Review
- Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study.Haematologica · 2018Article
- Anti-CD20 monoclonal antibodies: reviewing a revolution.Human vaccines & immunotherapeutics · 2018Article
- Tumor Lysis Syndrome in Chronic Lymphocytic Leukemia with Novel Targeted Agents.The oncologist · 2017Review
- Bendamustine and its role in the treatment of unfit patients with chronic lymphocytic leukaemia: a perspective review.Therapeutic advances in hematology · 2017Review
- Pharmacotherapy of relapsed/refractory chronic lymphocytic leukemia.Expert opinion on pharmacotherapy · 2017Review
- Current Treatment of Chronic Lymphocytic Leukemia.Current treatment options in oncology · 2017Review
- Article
- Optimal use of bendamustine in hematologic disorders: Treatment recommendations from an international consensus panel - an update.Leukemia & lymphoma · 2016Review
- New developments in the management of chronic lymphocytic leukemia: role of ofatumumab.OncoTargets and therapy · 2016Review
- [Progress of bendamustine in the treatment of B cell non-Hodgkin lymphoma].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2015Article
- Human organic cation transporter 1 (hOCT1) as a mediator of bendamustine uptake and cytotoxicity in chronic lymphocytic leukemia (CLL) cells.The pharmacogenomics journal · 2015Article
- 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
26 authors at 16 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We conducted a phase II, noncomparative, open-label, multicenter GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) study (CLL0809) to assess the efficacy and safety of bendamustine in combination with ofatumumab (BendOfa) in relapsed/refractory chronic lymphocytic leukemia (CLL). Forty-seven patients from 14 centers were evaluated. Therapy consisted of bendamustine (70 mg/m(2)) for 2 consecutive days every 28 days, and ofatumumab 300 mg on day 1 and 1000 mg on day 8 during the first cycle, and 1000 mg on day 1 subsequently. Treatment was administered up to six cycles. The overall response rate (ORR), as per intention-to-treat analysis, was 72.3% (95% confidence of interval (CI), 57-84%), with 17% complete responses. After a median follow-up of 24.2 months, the overall survival was 83.6% (95% CI, 73.0-95.7%) and the progression-free survival (PFS) was 49.6% (95% CI, 35.9-68.6%). The median PFS was 23.6 months. Univariate and multivariate analyses were used to identify clinical and biological characteristics associated with ORR and PFS. Myelosuppression was the most common toxicity; grade ≥3 neutropenia was observed in 61.7% of patients; however, grade ≥3 infections occurred in 6% of patients. BendOfa is feasible and effective in relapsed/refractory CLL patients, including patients with high-risk clinical and biological features.
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.