Evidence map›Paper›PMID 29419437›Full record

Trial reportHaematologica2018

Rituximab plus bendamustine or chlorambucil for chronic lymphocytic leukemia: primary analysis of the randomized, open-label MABLE study.

Anne-Sophie Michallet, Melih Aktan, Wolfgang Hiddemann, Osman Ilhan, Peter Johansson, Kamel Laribi, Balkis Meddeb, Carol Moreno, João Raposo, Anna Schuh and 7 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
7.0field-weighted citation impact, top 2% of its field
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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 14 institutions in 9 countries.

Anne-Sophie MichalletDepartment of Hematology, CLCC Centre Léon Bérard, Lyon, France.
Melih AktanIstanbul Medical Faculty, Istanbul University, Turkey.
Wolfgang HiddemannDepartment of Internal Medicine III, Ludwig-Maximilians University of Munich, Germany.
Osman IlhanDepartment of Hematology, Ankara University School of Medicine, Turkey.
Peter JohanssonDepartment of Hematology, Uddevalla Hospital, Sweden.
Kamel LaribiDepartment of Hematology, Centre Hospitalier du Mans, Le Mans, France.
Balkis MeddebHematology Department, Aziza Othmana University Hospital, Tunis, Tunisia.
Carol MorenoDepartment of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
João RaposoHematology Service, Hospital de Santa Maria, Lisbon, Portugal.
Anna SchuhDepartment of Oncology, Oxford University Hospitals, UK.
Ali ÜnalDepartment of Hematology, Erciyes University Medical School, Kayseri, Turkey.
Tom WideniusDepartment of Internal Medicine, Peijas Hospital, Vantaa, Finland.
Alf BernhardtProduct Development Medical Affairs, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Kerstin KellershohnMedical Affairs, Roche Pharma AG, Grenzach-Wyhlen, Germany.
Dimitri MesseriProduct Development Medical Affairs, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Stuart OsborneProduct Development Medical Affairs, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Véronique LeblondClinical Hematology, AP-HP Hôpital Pitié-Salpêtrière, UPMC University, Paris, France veronique.leblond@aphp.fr.
Roche (Switzerland) · CHAnkara University · TRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier du Mans · FRCentre Léon Bérard · FRErciyes University · TRHospital de Santa Maria · PTHospital de Sant Pau · ESIstanbul University · TRLudwig-Maximilians-Universität München · DEOxford University Hospitals NHS Trust · GBPeijas Hospital · FIRoche Pharma AG (Germany) · DEUddevalla sjukhus · SE

Funding

Department of Health
6 · The paper itself

Abstract

MABLE investigated the efficacy and safety of rituximab plus bendamustine or rituximab plus chlorambucil in fludarabine-ineligible patients with chronic lymphocytic leukemia. Patients received rituximab plus bendamustine or rituximab plus chlorambucil every four weeks for six cycles. Rituximab plus chlorambucil-treated patients without a complete response after Cycle 6 received chlorambucil monotherapy for at least six additional cycles or until complete response. The primary endpoint was complete response rate (confirmed by bone marrow biopsy) after Cycle 6 in first-line patients. Secondary endpoints included progression-free survival, overall survival, minimal residual disease, and safety. Overall, 357 patients were randomized (rituximab plus bendamustine, n=178; rituximab plus chlorambucil, n=179; intent-to-treat population), including 241 first-line patients (n=121 and n=120, respectively); 355 patients received treatment (n=177 and n=178, respectively; safety population). In first-line patients, complete response rate after Cycle 6 (rituximab plus bendamustine, 24%; rituximab plus chlorambucil, 9%;

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideChlorambucilFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedRemission InductionRituximabSurvival AnalysisTreatment OutcomeBendamustine HydrochlorideChlorambucilRituximab

Identifiers

PMID29419437
PMCPMC5865431
OpenAlexW2791345134

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.