Evidence map›Paper›PMID 34187401›Full record

ArticleBMC cancer2021

A phase II study of the PI3K inhibitor copanlisib in combination with the anti-CD20 monoclonal antibody rituximab for patients with marginal zone lymphoma: treatment rationale and protocol design of the COUP-1 trial.

Alexander Grunenberg, Lisa M Kaiser, Stephanie Woelfle, Birgit Schmelzle, Andreas Viardot, Peter Möller, Thomas F E Barth, Rainer Muche, Jens Dreyhaupt, Markus Raderer and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03474744 (Copanlisib and Rituximab in Marginal Zone Lymphoma Patients), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 27% 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.

NCT03474744 phase2active not recruitingnot on this map

Copanlisib and Rituximab in Marginal Zone Lymphoma Patients (COUP-1)

TypeinterventionalSponsorChristian BuskeRan2019 to 2027Enrolled36ConditionsMarginal Zone LymphomaArmsCopanlisib, Rituximab
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
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

12 authors at 3 institutions in 2 countries.

Alexander GrunenbergDepartment of Internal Medicine III, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. alexander.grunenberg@uniklinik-ulm.de.ORCID http://orcid.org/0000-0003-1632-917X
Lisa M KaiserComprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Stephanie WoelfleComprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Birgit SchmelzleComprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Andreas ViardotDepartment of Internal Medicine III, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Peter MöllerInstitute of Pathology, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Thomas F E BarthInstitute of Pathology, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Rainer MucheInstitute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, 89081, Ulm, Germany.
Jens DreyhauptInstitute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, 89081, Ulm, Germany.
Markus RadererDepartment of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.
Barbara KiesewetterDepartment of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.
Christian BuskeDepartment of Internal Medicine III, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Universität Ulm · DEUniversity Hospital Ulm · DEMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced stage marginal zone lymphoma (MZL) is an incurable indolent B-cell lymphoma, for which a wide variety of treatments ranging from single agent rituximab to more dose intense immunochemotherapy exists. One of the major goals in this palliative setting is to develop chemotherapy-free treatments, which approach the efficacy of immunochemotherapies, but avoid chemotherapy associated toxicity in this often elderly patient population. The PI3K inhibitor copanlisib has recently shown remarkable clinical activity in refractory or relapsed indolent B-cell lymphomas, among them MZL. Based on these data, copanlisib monotherapy was granted breakthrough designation by the FDA for the treatment of adult patients with relapsed marginal zone lymphoma who have received at least two prior therapies. However, data are still limited in particular for MZL. Based on this, the COUP-1 trial aims at testing the toxicity and efficacy of copanlisib in combination with rituximab in treatment naive and relapsed MZL.

methodsCOUP-1 is a prospective, multicenter, single-arm, open-label, non-randomized phase II trial of 6 cycles (28 days cycle) of copanlisib (60 mg intravenous day 1, 8, 15) and rituximab (375 mg/m DISCUSSION: The COUP-1 trial evaluates the efficacy and toxicity of the treatment of copanlisib in combination with rituximab in patients with MZL and additionally offers the chance for translational research in this heterogenous type of lymphoma.

trial registrationClinicalTrials.gov : NCT03474744 . Registration date: 03/23/2018.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsLymphoma, B-Cell, Marginal ZonePhosphoinositide-3 Kinase InhibitorsPyrimidinesQuinazolinesClinical Trials, Phase II as TopicHumansMulticenter Studies as TopicProspective StudiesAntibodies, MonoclonalcopanlisibPhosphoinositide-3 Kinase InhibitorsPyrimidinesQuinazolinesCopanlisibMarginal zone lymphomaPI3K inhibitorRituximab

Identifiers

PMID34187401
PMCPMC8243426
OpenAlexW3174436746

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.