Evidence map›Paper›PMID 15071604›Full record

Trial reportLeukemia2004

Consolidation with alemtuzumab in patients with chronic lymphocytic leukemia (CLL) in first remission--experience on safety and efficacy within a randomized multicenter phase III trial of the German CLL Study Group (GCLLSG).

C-M Wendtner, M Ritgen, C D Schweighofer, G Fingerle-Rowson, H Campe, G Jäger, B Eichhorst, R Busch, H Diem, A Engert and 6 more

Abstract readClinical TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 3 pooled it
15.1field-weighted citation impact, top 1% 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

65 citing papers in PubMed, 3 syntheses or guidelines pooled it, 268 citations in OpenAlex.

  1. Pooled it
  2. Alemtuzumab for patients with chronic lymphocytic leukaemia.The Cochrane database of systematic reviews · 2012
    Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Diagnosis ofInfection & chemotherapy · 2025
    Review
  13. Review
  14. Maintenance therapy for chronic lymphocytic leukaemia.The Cochrane database of systematic reviews · 2024
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. On the architecture of translational research designed to control chronic lymphocytic leukemia.Hematology. American Society of Hematology. Education Program · 2018
    Review
  20. Review

5 more citing papers are in PubMed but not listed here.

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

16 authors at 3 institutions in 1 country.

C-M WendtnerKlinikum Grosshadern, Medical Clinic III, Ludwig-Maximilians-University, Munich, Germany.
M Ritgen
C D Schweighofer
G Fingerle-Rowson
H Campe
G Jäger
B Eichhorst
R Busch
H Diem
A Engert
S Stilgenbauer
H Döhner
M Kneba
B Emmerich
M Hallek
German CLL Study Group (GCLLSG)
Ludwig-Maximilians-Universität München · DEUniversity Hospital Cologne · DEUniversity Hospital Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with CLL responding to initial chemotherapy with fludarabine alone (F) or in combination with cyclophosphamide (FC) were randomized for treatment with alemtuzumab (30 mg i.v. TIW, 12 weeks) or observation. Of 21 evaluable patients, 11 were randomized to alemtuzumab before the study was stopped due to severe infections in seven of 11 patients. These infections (one life-threatening pulmonary aspergillosis IV; four CMV reactivations III requiring i.v. ganciclovir; one pulmonary tuberculosis III; one herpes zoster III) were successfully treated and not associated with cumulative dose of alemtuzumab. In the observation arm, one herpes zoster infection II and one sinusitis I were documented. At 6 months after randomization, two patients in the alemtuzumab arm converted to CR, while three patients in the observation arm progressed. After alemtuzumab treatment, five of six patients achieved a molecular remission in peripheral blood while all patients in the observation arm remained MRD-positive (P=0.048). At 21.4 months median follow-up, patients receiving alemtuzumab showed a significant longer progression-free survival (no progression vs mean 24.7 months; P=0.036). In conclusion, a consolidation therapy with alemtuzumab is able to achieve molecular remissions and longer survival in CLL, but a safe treatment regimen needs to be determined.

Indexed as

AdultAgedAlemtuzumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeoplasmAntineoplastic AgentsDisease-Free SurvivalFemaleGermanyHumansInfectionsLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm, ResidualAlemtuzumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeoplasmAntineoplastic Agents

Identifiers

PMID15071604
OpenAlexW1968458944

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.