Evidence map›Paper›PMID 15540903›Full record

Trial reportInternational journal of hematology2004

Durable response but prolonged cytopenia after cladribine treatment in relapsed patients with indolent non-Hodgkin's lymphomas: results of a Japanese phase II study.

Michinori Ogura, Yasuo Morishima, Yukio Kobayashi, Naokuni Uike, Susumu Sugai, Takaaki Chou, Masaharu Kasai, Ikuo Miura, Tohru Murayama, Yoshihiro Matsuno and 5 more

Abstract readClinical TrialClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 13% 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, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Cladribine to Treat Relapsing Forms of Multiple Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
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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

15 authors at 9 institutions in 2 countries.

Michinori OguraDepartment of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan. mi-ogura@naa.att.ne.jp
Yasuo Morishima
Yukio Kobayashi
Naokuni Uike
Susumu Sugai
Takaaki Chou
Masaharu Kasai
Ikuo Miura
Tohru Murayama
Yoshihiro Matsuno
Shigeo Nakamura
Shigeo Mori
Yasuo Ohashi
Kensei Tobinai
Cladribine Study Group
Aichi Cancer Center · JPNational Cancer Center · USThe University of Tokyo · JPAkita University · JPKanazawa Medical University · JPNational Hospital Organization Kyushu Cancer Center · JPNiigata Cancer Center Hospital · JPSapporo Hokuyu Hospital · JPShiga Medical Center for Adults · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We conducted a phase II study to evaluate the efficacy and safety of cladribine (2-chlorodeoxyadenosine [2-CdA]) for patients with refractory or relapsed indolent B-cell lymphoma or mycosis fungoides. Forty-five patients were enrolled, and 43 patients, including 34 with follicular lymphoma, were eligible. 2-CdA was given by continuous intravenous infusion at a dose of 0.09 mg/kg daily for 7 consecutive days, and this schedule was repeated every 4 weeks up to a maximum of 6 cycles. The overall and complete response rates were 58.1% (25/43; 90% confidence interval, 44.5%-70.9%) and 14.0% (6/43), respectively. The disease progression-free proportions of all 43 eligible and all 25 responding patients at 2 years were 30.3% and 48.1%, respectively. Neutropenia and thrombocytopenia of grade 3 or 4 were observed in 53.3% and 37.8% of patients, respectively, with prolonged cytopenia observed in patients with increased numbers of treatment cycles. Nonhematologic toxicities of grade 3 or greater included diarrhea, arrhythmia, malaise, and gastrointestinal bleeding in 1 patient each, an increase in glutamic-pyruvic transaminase level in 2 patients, and infection in 5 patients. Two treatment-related deaths were observed. Four patients developed myelodysplastic syndrome (MDS) at 13 months to 2 years after completion of the 2-CdA treatments. 2-CdA is an active agent with acceptable toxicity for refractory or relapsed indolent lymphoma; however, prolonged myelosuppression and the potential development of MDS should be carefully monitored.

Indexed as

AdultAgedCladribineFemaleHumansJapanLymphoma, B-CellLymphoma, Non-HodgkinMaleMiddle AgedMycosis FungoidesMyelodysplastic SyndromesNeoplasms, Second PrimaryPancytopeniaRecurrenceRemission InductionCladribine

Identifiers

PMID15540903
OpenAlexW2042418843

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.