Evidence map›Paper›PMID 25765545›Full record

Trial reportLeukemia2015

Safety and efficacy of Temsirolimus in combination with Bendamustine and Rituximab in relapsed mantle cell and follicular lymphoma.

G Hess, U Keller, C W Scholz, M Witzens-Harig, J Atta, C Buske, S Kirschey, C Ruckes, C Medler, C van Oordt and 3 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.5field-weighted citation impact, top 4% 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

14 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Mantle cell lymphoma and its management: where are we now?Experimental hematology & oncology · 2019
    Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. 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

13 authors at 8 institutions in 1 country.

G HessDepartment of Internal Medicine III (Hematology, Oncology, Pneumology), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.ORCID 0000000292825688
U KellerIII. Medical Department, Technical University Munich, Munich, Germany.
C W ScholzDepartment of Hematology, Oncology, Charité - University Medical School Berlin, Berlin, Germany.
M Witzens-HarigDepartment of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
J AttaDepartment of Internal Medicine II, Center of Internal Medicine, Johann Wolfgang Goethe-University, Frankfurt, Germany.
C BuskeInstitute of Experimental Cancer Research and Department of Internal Medicine III, University Hospital, Ulm, Germany.
S KirscheyDepartment of Internal Medicine III (Hematology, Oncology, Pneumology), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
C RuckesInterdisciplinary Centre for Clinical Trials (IZKS), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
C MedlerInterdisciplinary Centre for Clinical Trials (IZKS), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
C van OordtDepartment of Internal Medicine III (Hematology, Oncology, Pneumology), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
W KlapperDivision of Hematophathology, Christian-Albrechts-University, Kiel, Germany.
M TheobaldDepartment of Internal Medicine III (Hematology, Oncology, Pneumology), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
M DreylingDepartment of Internal Medicine III, Ludwig-Maximilians-University, Munich, Germany.
Johannes Gutenberg University Mainz · DEChristian-Albrechts-Universität zu Kiel · DEGoethe University Frankfurt · DEHeidelberg University · DELudwig-Maximilians-Universität München · DEMSB Medical School Berlin · DETechnical University of Munich · DEUniversity Hospital Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this phase I/II study, we explored the combination of Temsirolimus with Bendamustine and Rituximab (BeRT) in patients with r/r follicular lymphoma (FL) or mantle cell lymphoma (MCL). Patients with 1-3 prior therapies received Bendamustine (90 mg/m(2), day 1+2) and Rituximab (375 mg/m(2), day 1) with Temsirolimus in doses from 25 to 75 mg added on day 1, 8, 15 of a 28-day cycle. Fifteen (11 MCL, 4 FL) patients were included in the phase I. Median age was 73 years and median pretreatment number was 2. No formal dose-limiting toxicity was observed. Dominant non-hematological side effects were fatigue in 11 (73%), nausea in 9 (60%), mucositis in 7 (47%) and vomiting in 6 patients (40%). Cough, diarrhea, pyrexia and rash were observed in five patients (33%) each. Grade 3/4 events included leukopenia in 6 (40%), neutropenia in 4 (27%) and thrombocytopenia in 2 patients (13%). An objective response was observed in 14/15 patients (93%), including 5 complete response (33%; all MCL). After a median follow-up of 19 months, 67% of patients are without signs of progression. Temsirolimus can be safely added to BR with promising preliminary activity. Recruitment in phase II is ongoing.

Indexed as

AgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideFeasibility StudiesFemaleFollow-Up StudiesHumansLymphoma, FollicularLymphoma, Mantle-CellMaleMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingNitrogen Mustard CompoundsAntibodies, Monoclonal, Murine-DerivedBendamustine HydrochlorideNitrogen Mustard CompoundsRituximabSirolimustemsirolimus

Identifiers

PMID25765545
OpenAlexW2081483209

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.