Evidence map›Paper›PMID 34979020›Full record

ArticleBlood advances2022

Blinatumomab in pediatric relapsed/refractory B-cell acute lymphoblastic leukemia: RIALTO expanded access study final analysis.

Franco Locatelli, Gerhard Zugmaier, Noemi Mergen, Peter Bader, Sima Jeha, Paul-Gerhardt Schlegel, Jean-Pierre Bourquin, Rupert Handgretinger, Benoit Brethon, Claudia Rössig and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02187354 (An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia), which is not on this map. Cited by 54 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing 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.

NCT02187354 no longer availablenot on this map

An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Typeexpanded_accessSponsorAmgenConditionsRelapsed/Refractory B-Precursor Acute Lymphoblastic LeukemiaArmsBlinatumomab, Extension of LTFU as per ProtocolAmendment7 7Jun18
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Pooled it
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  7. Article
  8. Article
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  15. Article
  16. Novel Therapeutic Approaches in Pediatric Acute Lymphoblastic Leukemia.International journal of molecular sciences · 2025
    Review
  17. Article
  18. Review
  19. Review
  20. Observational
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

13 authors.

Franco LocatelliDepartment of Hematology and Oncology, IRCCS Bambino Gesù Children's Hospital, Sapienza, University of Rome, Rome, Italy.
Gerhard ZugmaierAmgen Research (Munich) GmbH, Munich, Germany.
Noemi MergenAmgen Research (Munich) GmbH, Munich, Germany.
Peter BaderDepartment for Children and Adolescents, University Hospital Frankfurt, Frankfurt, Germany.ORCID 0000-0003-4554-0265
Sima JehaGlobal Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.
Paul-Gerhardt SchlegelDepartment of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital Würzburg, Würzburg, Germany.
Jean-Pierre BourquinDepartment of Pediatric Oncology, Children's Research Centre, University Children's Hospital Zürich, Zürich, Switzerland.
Rupert HandgretingerHematology/Oncology, University Children's Hospital Tübingen, Tübingen, Germany.
Benoit BrethonPediatric Hematology and Immunology Department, Robert-Debré Hospital, AP-HP, Paris, France.
Claudia RössigPediatric Hematology and Oncology, University Children's Hospital Münster, Münster, Germany.
William N KormanyGlobal Patient Safety, Amgen Inc., Thousand Oaks, CA.
Puneeth ViswagnacharBiostatistical Sciences, IQVIA, Bangalore, India.
Christiane Chen-SantelDepartment of Pediatrics, Division of Oncology and Hematology, Charité Universitätsmedizin Berlin, Berlin, Germany; and.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety and efficacy of blinatumomab, a CD3/CD19-directed bispecific molecule, were examined in an open-label, single-arm, expanded access study (RIALTO). Children (>28 days and <18 years) with CD19+ relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) received up to 5 cycles of blinatumomab by continuous infusion (cycle: 4 weeks on/2 weeks off). The primary end point was incidence of adverse events. Secondary end points included complete response (CR) and measurable residual disease (MRD) response within the first 2 cycles and relapse-free survival (RFS), overall survival (OS), and allogeneic hematopoietic stem cell transplant (alloHSCT) after treatment. At final data cutoff (10 January 2020), 110 patients were enrolled (median age, 8.5 years; 88% had ≥5% baseline blasts). A low incidence of grade 3 or 4 cytokine release syndrome (n = 2; 1.8%) and neurologic events (n = 4; 3.6%) was reported; no blinatumomab-related fatal adverse events were recorded. The probability of response was not affected by the presence of cytogenetic/molecular abnormalities. Median OS was 14.6 months (95% confidence interval [CI]: 11.0-not estimable) and was significantly better for MRD responders vs MRD nonresponders (not estimable vs 9.3; hazard ratio, 0.18; 95% CI: 0.08-0.39). Of patients achieving CR after 2 cycles, 73.5% (95% CI: 61.4%-83.5%) proceeded to alloHSCT. One-year OS probability was higher for patients who received alloHSCT vs without alloHSCT after blinatumomab (87% vs 29%). These findings support the use of blinatumomab as a safe and efficacious treatment of pediatric R/R B-ALL. This trial was registered at www.clinicaltrials.gov as #NCT02187354.

Indexed as

Antibodies, BispecificLymphoma, B-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaAntigens, CD19CD3 ComplexChildHumansNeoplasm, ResidualAntibodies, BispecificAntigens, CD19blinatumomabCD3 Complex

Identifiers

PMID34979020
PMCPMC8945309

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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.