Evidence map›Paper›PMID 25804339›Full record

Trial reportLeukemia research2015

Final results of EFC6663: a multicenter, international, phase 2 study of alvocidib for patients with fludarabine-refractory chronic lymphocytic leukemia.

Mark C Lanasa, Leslie Andritsos, Jennifer R Brown, Janice Gabrilove, Federico Caligaris-Cappio, Paolo Ghia, Richard A Larson, Thomas J Kipps, Veronique Leblond, Donald W Milligan and 9 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyValidation Study
In one paragraph

Trial report in Leukemia research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.0field-weighted citation impact, top 6% 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

23 citing papers in PubMed, 50 citations in OpenAlex.

  1. Review
  2. Article
  3. A preclinical platform for assessing antitumor effects and systemic toxicities of cancer drug targets.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Cell Death Pathways in Lymphoid Malignancies.Current oncology reports · 2020
    Review
  10. Article
  11. Article
  12. Cyclin-dependent kinase 1 and survivin as potential therapeutic targets against nasal natural killer/T-cell lymphoma.Laboratory investigation; a journal of technical methods and pathology · 2019
    Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
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 12 institutions in 5 countries.

Mark C LanasaDuke University Medical Center, Durham, NC, United States.
Leslie AndritsosThe Ohio State University, Columbus, OH, United States.
Jennifer R BrownDana-Farber/Harvard Cancer Center, Boston, MA, United States.
Janice GabriloveIcahn School of Medicine at Mount Sinai, New York, NY, United States.
Federico Caligaris-CappioDepartment of Onco-Hematology and Division of Molecular Oncology, Istituto Scientifico San Raffaele and Università, Vita-Salute San Raffaele, Milan, Italy.
Paolo GhiaDepartment of Onco-Hematology and Division of Molecular Oncology, Istituto Scientifico San Raffaele and Università, Vita-Salute San Raffaele, Milan, Italy.
Richard A LarsonUniversity of Chicago, Chicago, IL, United States.
Thomas J KippsMoores UCSD Cancer Center, San Diego, CA, United States.
Veronique LeblondHôpital pitié Salpêtrière, Université Pierre et Marie Curie GRC11-GRECHY, Paris, France.
Donald W MilliganBirmingham Heartlands Hospital, Birmingham, UK.
Ann JanssensUniversity Hospitals Leuven, Leuven, Belgium.
Amy J JohnsonThe Ohio State University, Columbus, OH, United States.
Nyla A HeeremaThe Ohio State University, Columbus, OH, United States.
Andreas BühlerDepartment of Internal Medicine III, Ulm University, Ulm, Germany.
Stephan StilgenbauerDepartment of Internal Medicine III, Ulm University, Ulm, Germany.
Jeanne DevinSanofi, Bridgewater, NJ, United States.
Michael HallekUniversity of Cologne, Cologne, Germany.
John C ByrdThe Ohio State University, Columbus, OH, United States. Electronic address: john.byrd@osumc.edu.
Michael R GreverThe Ohio State University, Columbus, OH, United States.
The Ohio State University · USUniversität Ulm · DEVita-Salute San Raffaele University · ITDana-Farber/Harvard Cancer Center · USDuke Medical Center · USHeartlands Hospital · GBIcahn School of Medicine at Mount Sinai · USMoores Cancer CenterSanofi (United States) · USSorbonne Université · FRUniversity of Chicago · USUniversity of Cologne · DE

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
TWO SIGNAL REQUIREMENT FOR NATURAL KILLER IMMUNITYP01CA095426 · NCI · OHIO STATE UNIVERSITY · PI MUTHUSAMY, NATARAJAN · 2002 to 2016
$29.6M
NCI NIH HHS P01 CA081534NCI NIH HHS P01 CA095426NCI NIH HHS P30 CA016058
6 · The paper itself

Abstract

Early phase studies of alvocidib showed activity in relapsed CLL including patients with high risk genomic features and those refractory to fludarabine. A multi-center, international, phase II study of alvocidib in fludarabine refractory CLL was undertaken to validate these early results. Patients with fludarabine refractory CLL or prolymphocytic leukemia arising from CLL were treated with single agent alvocidib. The primary outcome measure was overall response rate, with secondary outcomes including survival, toxicity, and response duration. One hundred and sixty five patients were enrolled and 159 patients were treated. The median age was 61 years, the median number of prior therapies was 4, and 96% of patients were fludarabine refractory. The investigator-assessed overall response rate was 25%; the majority of responses were partial. Response rates were lower among patients with del(17p) (14%), but equivalent in patients with del(11q) or bulky lymphadenopathy. Median progression free and overall survival were 7.6 and 14.6 months, respectively. Tumor lysis occurred in 39 patients (25%), and 13 received hemodialysis. Diarrhea, fatigue, and hematologic toxicities were common. Alvocidib has clinical activity in patients with advanced, fludarabine refractory CLL. Future studies should focus on discovery of biomarkers of clinical response and tumor lysis, and enhanced supportive care measures.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsFemaleFlavonoidsHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPiperidinesRecurrenceSurvival AnalysisTreatment FailureVidarabinealvocidibAntineoplastic AgentsFlavonoidsfludarabinePiperidinesVidarabineChronic lymphocytic leukemiaCyclin dependent kinase inhibitorFlavopiridolTherapyTumor lysis syndrome

Identifiers

PMID25804339
PMCPMC4557608
OpenAlexW1987880662

What OpenQuestion holds

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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.