Evidence map›Paper›PMID 29749403›Full record

Trial reportLeukemia2018

Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study.

Stephan Stilgenbauer, Veronique Leblond, Robin Foà, Sebastian Böttcher, Osman Ilhan, Wolfgang Knauf, Eva Mikuskova, Christoph Renner, Eugen Tausch, Dariusz Woszczyk and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Leukemia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01905943 (A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 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.

NCT01905943 phase3completednot on this map

A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2018Enrolled979ConditionsChronic Lymphocytic LeukemiaArmsBendamustine, Chlorambucil, Cyclophosphamide, Fludarabine, Obinutuzumab
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  15. Anti-CD20 monoclonal antibodies: reviewing a revolution.Human vaccines & immunotherapeutics · 2018
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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

16 authors.

Stephan StilgenbauerDepartment of Internal Medicine III, Ulm University, Ulm, Germany. Stephan.Stilgenbauer@uniklinik-ulm.de.
Veronique LeblondUPMC GRC11-GRECHY, AP-HP Hôpital Pitié Salpêtrière, Paris, France.
Robin FoàDepartment of Cellular Biotechnologies and Hematology, 'Sapienza' University, Rome, Italy.
Sebastian BöttcherSecond Department of Medicine, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Osman IlhanAnkara University, Ankara, Turkey.
Wolfgang KnaufOnkologische Gemeinschaftspraxis, Agaplesion Bethanien Krankenhaus, Frankfurt, Germany.
Eva MikuskovaNational Cancer Institute, Bratislava, Slovakia.
Christoph RennerOnkoZentrum Zürich, Zürich, Switzerland.
Eugen TauschDepartment of Internal Medicine III, Ulm University, Ulm, Germany.
Dariusz WoszczykState Hospital, Opole, Poland.
Ekaterina GreskoF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Linda LundbergF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Tom MooreF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Thea MorrisF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Susan RobsonF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Francesc BoschUniversity Hospital Vall d'Hebron, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

GREEN (NCT01905943) is a non-randomized, open-label phase IIIb study investigating obinutuzumab alone or plus chemotherapy in chronic lymphocytic leukemia (CLL). We report a preplanned subgroup analysis of 158 previously untreated CLL patients receiving obinutuzumab-bendamustine (G-B). Patients received six 28-day cycles (C) of G-B: obinutuzumab day (D)1/D2 of C1 (25 mg D1/975 mg D2), 1000 mg D8 and D15 of C1, and D1 of C2-6; and bendamustine 70/90 mg/m

Indexed as

Salvage TherapyAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm, ResidualAntibodies, Monoclonal, HumanizedBendamustine HydrochlorideobinutuzumabRituximab

Identifiers

PMID29749403
PMCPMC6087718

What OpenQuestion holds

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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.