Evidence map›Paper›PMID 23228986›Full record

Trial reportCancer chemotherapy and pharmacology2013

Acadesine for patients with relapsed/refractory chronic lymphocytic leukemia (CLL): a multicenter phase I/II study.

Eric Van Den Neste, Bruno Cazin, Ann Janssens, Eva González-Barca, María José Terol, Vincent Levy, Jaime Pérez de Oteyza, Pierre Zachee, Andrew Saunders, Mercè de Frias and 1 more

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

Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

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  11. Metabolic Reprogramming and Potential Therapeutic Targets in Lymphoma.International journal of molecular sciences · 2023
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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

11 authors at 9 institutions in 4 countries.

Eric Van Den NesteHematology Department, Cliniques universitaires UCL Saint-Luc, Brussels, Belgium. eric.vandenneste@uclouvain.be
Bruno Cazin
Ann Janssens
Eva González-Barca
María José Terol
Vincent Levy
Jaime Pérez de Oteyza
Pierre Zachee
Andrew Saunders
Mercè de Frias
Clara Campàs
Centre Hospitalier Universitaire de Lille · FRCliniques Universitaires Saint-Luc · BEHôpital Avicenne · FRHospital Clínico Universitario de Valencia · ESHospital Universitario HM Sanchinarro · ESInstitut Català d'Oncologia · ESKU Leuven · BELinden Photonics (United States) · USZiekenhuisnetwerk Antwerpen Stuivenberg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAcadesine has shown in vitro to selectively induce apoptosis in B cells from chronic lymphocytic leukemia (CLL) patients. We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.

methodsPatient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen. Twenty-four patients were included: eighteen in Part I treated at single doses of 50-315 mg/kg, and six in Part II, three with two doses at 210 mg/kg and three with five doses at 210 mg/kg.

resultsA manageable and predictable safety profile was demonstrated for acadesine at single doses between 50 and 210 mg/kg; 210 mg/kg was the maximum tolerated dose (MTD) and optimal biological dose (OBD). Grade ≥2 hyperuricemia occurred commonly but was not clinically significant and resolved with the administration of prophylactic allopurinol. Other adverse events included transient anemia and/or thrombocytopenia (not clinically significant), renal impairment, and transient infusion-related hypotension (clinically significant). Trends of efficacy such as a reduction of peripheral CLL cells and reduction in lymphadenopathy were observed; however, the results were variable due to the small population and the range of doses tested.

conclusionsA MTD of 210 mg/kg was established with single acadesine dose. Multiple dose administrations at the OBD were tested with an acceptable safety profile, showing that acadesine might be a valuable agent for the treatment of relapsed/refractory CLL patients.

Indexed as

AgedAminoimidazole CarboxamideB-LymphocytesCohort StudiesDrug Resistance, NeoplasmFemaleHumansKarnofsky Performance StatusLeukemia, Lymphocytic, Chronic, B-CellLymphLymphocyte CountMaleMaximum Tolerated DoseMiddle AgedRecurrenceRibonucleosidesacadesineAminoimidazole CarboxamideRibonucleosides

Identifiers

PMID23228986
PMCPMC3579463
OpenAlexW2118637676

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.