Evidence map›Paper›PMID 19641526›Full record

Trial reportLeukemia2009

Low-dose subcutaneous alemtuzumab in refractory chronic lymphocytic leukaemia (CLL): results of a prospective, single-arm multicentre study.

A Cortelezzi, M C Pasquini, A Gardellini, U Gianelli, A Bossi, G Reda, B Sarina, P Musto, W Barcellini, A Neri and 1 more

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

Trial report in Leukemia, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.9field-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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Alemtuzumab for patients with chronic lymphocytic leukaemia.The Cochrane database of systematic reviews · 2012
    Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Treatment options for high-risk chronic lymphocytic leukaemia.Therapeutic advances in hematology · 2011
    Article
  10. Review
  11. Something new under the skin.Nature biotechnology · 2011
    Article
  12. Anti-inflammatory treatment of uveitis with biologicals: new treatment options that reflect pathogenetic knowledge of the disease.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2010
    Review
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

A CortelezziDepartment of Medical Sciences, University of Milan, Milan, Italy. agostino.cortelezzi@unimi.it
M C Pasquini
A Gardellini
U Gianelli
A Bossi
G Reda
B Sarina
P Musto
W Barcellini
A Neri
G L Deliliers
Ospedale Maggiore · ITUniversity of Milan · ITCentro di Riferimento Oncologico della Basilicata · ITFondazione Humanitas per la Ricerca · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Alemtuzumab is active in chronic lymphocytic leukaemia (CLL) patients refractory to alkylators and fludarabine. The aim of this study was to determine the efficacy and safety of subcutaneous alemtuzumab at low dose (10 mg three times per week, for 18 weeks) to 49 patients with pre-treated CLL. The overall response rate was 53%, including 27% of complete responses; it was 42% in patients over 70 years, and 54% in the fludarabine-resistant patients. Forty-five percent of the patients with an unfavourable karyotype responded, including 60% of those with the 17p- aberration. After a median follow-up of 25 months, the median overall time to disease progression was 8 months (responders 12 months, non-responders 4 months). The median overall time to alternative treatment was 9 months (responders 17 months, non-responders 6 months) and median overall survival was 30 months. The treatment was well tolerated: grade IV neutropenia was observed in 17%, and cytomegalovirus (CMV) reactivation in 24% of the patients, with no CMV disease. We observed a total of 30 infections (50% during treatment and 50% during the 12-month follow-up), only one-third of which was severe. This study confirms that low-dose subcutaneous alemtuzumab is effective in poor prognosis CLL, and has a particularly favourable toxicity profile.

Indexed as

AdultAgedAged, 80 and overAlemtuzumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeoplasmAntineoplastic AgentsDisease ProgressionDose-Response Relationship, DrugDrug Resistance, NeoplasmFemaleHumansInjections, SubcutaneousKaplan-Meier EstimateLeukemia, Lymphocytic, Chronic, B-CellAlemtuzumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeoplasmAntineoplastic Agents

Identifiers

PMID19641526
OpenAlexW2133254493

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.