Evidence map›Paper›PMID 31801940›Full record

Trial reportBlood cancer journal2019

Ofatumumab maintenance prolongs progression-free survival in relapsed chronic lymphocytic leukemia: final analysis of the PROLONG study.

Marinus van Oers, Lukas Smolej, Mario Petrini, Fritz Offner, Sebastian Grosicki, Mark-David Levin, Jaclyn Davis, Hiya Banerjee, Tommaso Stefanelli, Petra Hoever and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood cancer journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Maintenance therapy for chronic lymphocytic leukaemia.The Cochrane database of systematic reviews · 2024
    Review
  6. Review
  7. Review
  8. Is there a role for anti-CD20 antibodies in CLL?Hematology. American Society of Hematology. Education Program · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Marinus van OersAcademisch Medisch Centrum and HOVON, Amsterdam, The Netherlands. m.h.vanoers@amc.uva.nl.
Lukas SmolejUniversity Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.
Mario PetriniAzienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Fritz OffnerUniversitair Ziekenhuis Gent, Gent, Belgium.
Sebastian GrosickiDepartment of Hematology and Cancer Prevention, Silesian Medical University, Katowice, Poland.ORCID http://orcid.org/0000-0003-2644-1050
Mark-David LevinAlbert Schweitzer Ziekenhuis Dordrecht and HOVON, Dordrecht, The Netherlands.
Jaclyn DavisNovartis Oncology, East Hanover, NJ, USA.
Hiya BanerjeeNovartis Oncology, East Hanover, NJ, USA.
Tommaso StefanelliNovartis Pharma AG, Basel, Switzerland.
Petra HoeverNovartis Pharma AG, Basel, Switzerland.
Christian GeislerRigshospitalet-Koebenhavn, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report the final analysis of the PROLONG study on ofatumumab maintenance in relapsed chronic lymphocytic leukemia (CLL). In all, 480 patients with CLL in complete or partial remission after second- or third-line treatment were randomized 1:1 to ofatumumab (300 mg first week, followed by 1000 mg every 8 weeks for up to 2 years) or observation. Median follow-up duration was 40.9 months. Median progression-free survival was 34.2 and 16.9 months for ofatumumab and observation arms, respectively, (hazard ratio, 0.55 [95% confidence interval, 0.43-0.70]; P < 0.0001). Median time to next treatment for ofatumumab and observation arms, respectively, was 37.4 and 27.6 months (0.72 [0.57-0.91]; P = 0.0044). Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]). Grade ≥ 3 adverse events occurred in 62% and 51% of patients in ofatumumab and observation arms, respectively, the most common being neutropenia (23% and 10%), pneumonia (13% and 12%) and febrile neutropenia (6% and 4%). Up to 60 days after the last treatment, four deaths were reported in the ofatumumab arm versus six in the observation arm, none considered related to ofatumumab. Ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaintenance ChemotherapyMaleMiddle AgedRecurrenceRetreatmentTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalofatumumab

Identifiers

PMID31801940
PMCPMC6893027

What OpenQuestion holds

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Registered trials

None linked

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.