Evidence map›Paper›PMID 30030507›Full record

ArticleLeukemia2018

Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.

Robert J Kreitman, Claire Dearden, Pier Luigi Zinzani, Julio Delgado, Lionel Karlin, Tadeusz Robak, Douglas E Gladstone, Philipp le Coutre, Sascha Dietrich, Mirjana Gotic and 33 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article 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 NCT01829711 (A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia), which is not on this map. Cited by 137 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 2 pooled it
13.5field-weighted citation impact, top 1% 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.

NCT01829711 phase3completednot on this map

A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

TypeinterventionalSponsorMedImmune LLCRan2013 to 2019Enrolled80ConditionsLeukemia, Hairy CellArmsMoxetumomab pasudotox, IV Bag Protectant for Moxetumomab pasudotox
3 · Its place in the literature

Who cites it

137 citing papers in PubMed, 2 syntheses or guidelines pooled it, 240 citations in OpenAlex.

  1. Guideline
  2. [Chinese guideline for diagnosis and treatment of hairy cell leukemia (2023)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2023
    Guideline
  3. Trial
  4. Trial
  5. Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  6. Trial
  7. Review
  8. Journal of ginseng research · 2026
    Review
  9. CD22 as a Target for Hematological Malignancies and Autoimmune Diseases.International journal of molecular sciences · 2026
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article

77 more citing papers are in PubMed but not listed here.

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

43 authors at 20 institutions in 14 countries.

Robert J KreitmanNational Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Claire DeardenThe Royal Marsden NHS Foundation Trust, London, UK.
Pier Luigi ZinzaniInstitute of Hematology, Seràgnoli University of Bologna, Bologna, Italy.
Julio DelgadoHospital Clinic, Barcelona, Spain.
Lionel KarlinCentre Hospitalier Lyon Sud, Pierre-bénite, France.
Tadeusz RobakMedical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
Douglas E GladstoneJohns Hopkins Kimmel Cancer Center, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-8484-2990
Philipp le CoutreCharité Universitätsmedizin, Berlin, Germany.
Sascha DietrichUniversitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany.
Mirjana GoticClinical Center of Serbia, Belgrade, Serbia.ORCID http://orcid.org/0000-0002-8590-0328
Loree LarrattUniversity of Alberta, Edmonton, Alberta, Canada.
Fritz OffnerGhent University Hospital, Ghent, Belgium.
Gary SchillerDavid Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
Ronan SwordsSylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA.
Larry BaconSt. James's Hospital, Dublin, Ireland.
Monica BocchiaAzienda Ospedaliera Universitaria, University of Siena, Siena, Italy.
Krimo BouabdallahService d'hématologie, CHU Bordeaux, F-33000, Bordeaux, France.
Dimitri A BreemsZiekenhuis Netwerk Antwerpe, Antwerp, Belgium.
Agostino CortelezziFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Shira DinnerNorthwestern Medicine Feinberg School of Medicine, Chicago, IL, USA.
Michael DoubekMasaryk University, Brno, Czech Republic.
Bjorn Tore GjertsenHelse Bergen HF Haukeland University Hospital, Bergen, Norway.ORCID http://orcid.org/0000-0001-9358-9704
Marco GobbiClinic of Hematology, Ospedale Policlinico San Martino, Genova, Italy.
Andrzej HellmannDepartment of Hematology and Transplantation, Medical University of Gdańsk, Gdańsk, Poland.
Stephane LepretreInserm U1245 and Department of Hematology, Centre Henri Becquerel and Normandie Univ UNIROUEN, Rouen, France.
Frederic MaloiselSOL, Clinique Sainte-Anne, Strasbourg, France.
Farhad RavandiMD Anderson Cancer Center, Houston, TX, USA.
Philippe RousselotCentre Hospitalier de Versailles, INSERM U1173, Le Chesnay, France.
Mathias RummelJustus-Liebig University, Giessen, Germany.
Tanya SiddiqiCity of Hope National Medical Center, Duarte, CA, USA.
Tamar TadmorBnai Zion Medical Center, Haifa, Israel.
Xavier TroussardL'hôpital Côte de Nacre, Caen Cedex 9, Caen, France.
Cecilia Arana YiUniversity of New Mexico, Albuquerque, NM, USA.
Giuseppe SaglioUniversity of Turin, Turin, Italy.
Gail J RobozWeill Cornell Medicine, The New York Presbyterian Hospital, New York, NY, USA.
Kemal BalicMedImmune, South San Francisco, CA, USA.
Nathan StandiferMedImmune, South San Francisco, CA, USA.
Peng HeMedImmune, Gaithersburg, MD, USA.
Shannon MarshallMedImmune, Gaithersburg, MD, USA.
Wyndham WilsonNational Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Ira PastanNational Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Nai-Shun YaoMedImmune, Gaithersburg, MD, USA.
Francis GilesDevelopmental Therapeutics Consortium, Chicago, IL, USA. frankgiles@aol.com.
National Institutes of Health · USInserm · FRSerimmune (United States) · USBarcelona Centre for International Affairs · ESBnai Zion Medical Center · ILCentar za Promociju Nauke · RSCentre Hospitalier Sainte-Anne · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Caen Normandie · FRCharité - Universitätsmedizin Berlin · DECity Of Hope National Medical Center · USCopernicus Memorial Hospital · PLGdańsk Medical University · PLGhent University Hospital · BEHaukeland University Hospital · NOHeidelberg University · DEHospices Civils de Lyon · FRJohns Hopkins University · USJustus-Liebig-Universität Gießen · DEMasaryk University · CZ

Funding

Clinical Trials with ImmunotoxinsZIABC010020 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI PASTAN, IRA · 2009 to 2022
$11.7M
Phase I study of bortezomib and DA-EPOCH-R with microarray in DLBCLZIABC010717 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WILSON, WYNDHAM H · 2009 to 2021
$1.7M
6 · The paper itself

Abstract

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Indexed as

Salvage TherapyAdultAgedAged, 80 and overAntineoplastic AgentsBacterial ToxinsDrug Resistance, NeoplasmExotoxinsFemaleFollow-Up StudiesHumansLeukemia, Hairy CellMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisAntineoplastic AgentsBacterial ToxinsExotoxinsimmunotoxin HA22

Identifiers

PMID30030507
PMCPMC6087717
OpenAlexW2884362356

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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.