Evidence map›Paper›PMID 31097627›Full record

Trial reportHaematologica2019

Olaptesed pegol (NOX-A12) with bendamustine and rituximab: a phase IIa study in patients with relapsed/refractory chronic lymphocytic leukemia.

Michael Steurer, Marco Montillo, Lydia Scarfò, Francesca R Mauro, Johannes Andel, Sophie Wildner, Livio Trentin, Ann Janssens, Sonja Burgstaller, Anna Frömming and 9 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% 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

48 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Aptamers in cancer therapy: Why has clinical translation lagged behind preclinical promise?Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2026
    Review
  4. Review
  5. RNA therapeutic targeting of recalcitrant and rare cancers.Exploration of targeted anti-tumor therapy · 2026
    Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Nucleic acid drugs: recent progress and future perspectives.Signal transduction and targeted therapy · 2024
    Review
  17. Review
  18. Review
  19. Review
  20. CXC chemokine receptor 4 (CXCR4) blockade in cancer treatment.Journal of cancer research and clinical oncology · 2023
    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

19 authors at 11 institutions in 4 countries.

Michael SteurerDivision of Hematology and Oncology, Innsbruck Medical University, Innsbruck, Austria.
Marco MontilloDepartment of Hematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.
Lydia ScarfòUniversità Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele, Milan, Italy.
Francesca R MauroHematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy.
Johannes AndelMedical Dept. 2, County Hospital, Steyr, Austria.
Sophie WildnerDivision of Hematology and Oncology, Innsbruck Medical University, Innsbruck, Austria.
Livio TrentinDepartment of Medicine, Hematology and Clinical Immunology Branch, University of Padua, Padua, Italy.
Ann JanssensDepartment of Hematology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
Sonja BurgstallerDepartment of Internal Medicine IV, Wels-Grieskirchen Hospital, Wels, Austria.
Anna FrömmingNOXXON Pharma, Berlin, Germany.
Thomas DümmlerNOXXON Pharma, Berlin, Germany.
Kai RieckeNOXXON Pharma, Berlin, Germany.
Matthias BaumannNOXXON Pharma, Berlin, Germany.
Diana BeyerNOXXON Pharma, Berlin, Germany.
Stéphanie VauléonNOXXON Pharma, Berlin, Germany.
Paolo GhiaUniversità Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele, Milan, Italy.
Robin FoàHematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy.
Federico Caligaris-CappioUniversità Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele, Milan, Italy.
Marco GobbiHaematology Clinic, Department of Internal Medicine, University of Genoa, and Ospedale Policlinico S. Martino, Clinica Ematologica, Genoa, Italy gobbi@unige.it.
Noxxon Pharma (Germany) · DEInnsbruck Medical University · ATIstituti di Ricovero e Cura a Carattere Scientifico · ITMologen (Germany) · DESapienza University of Rome · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITKlinikum Wels-Grieskirchen · ATOspedale Policlinico San Martino · ITUniversitair Ziekenhuis Leuven · BEUniversity of Padua · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Olaptesed pegol (NOX-A12) is a pegylated structured L-oligoribonucleotide that binds and neutralizes CXCL12, a chemokine tightly regulating the life cycle of chronic lymphocytic leukemia cells. The resulting inhibition of CXCR4 and CXCR7 signaling reduces the protective activity of the bone marrow and lymph node microenvironment. CXCL12 inhibition mobilizes chronic lymphocytic leukemia cells into the circulation and prevents their homing into the protective niches. In this phase I/II study, 28 patients with relapsed/refractory chronic lymphocytic leukemia were treated with olaptesed pegol in combination with bendamustine and rituximab. Combination treatment was preceded by single escalating pilot doses of olaptesed pegol in the first ten patients for evaluation of safety and pharmacokinetics. Peak concentrations and systemic exposure of olaptesed pegol were dose-linear; plasma elimination was monophasic with a 53.2 h half-life. A rapid increase in circulating chronic lymphocytic leukemia cells was observed already 1 h after administration of olaptesed pegol and lasted for at least 72 h. Single-agent treatment was well tolerated and no dose-limiting toxicity was observed. The combination regimen yielded an overall response rate of 86%, with 11% of patients achieving a complete response and 75% a partial response. Notably, all ten high-risk patients, including four with a 17p deletion, responded to treatment. The median progression-free survival was 15.4 (95% confidence interval: 12.2, 26.2) months while the median overall survival was not reached with >80% of patients alive after a median follow-up of 28 months. Olaptesed pegol was well tolerated and did not result in additional toxicity when combined with bendamustine and rituximab (

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLeukemia, Lymphocytic, Chronic, B-CellAdultAgedAptamers, NucleotideBendamustine HydrochlorideDisease-Free SurvivalFemaleHumansMaleMiddle AgedRecurrenceRituximabSurvival RateAptamers, NucleotideBendamustine HydrochlorideNOX-A12Rituximab

Identifiers

PMID31097627
PMCPMC6886437
OpenAlexW2946505679

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Registered trials

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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.