Evidence map›Paper›PMID 26194764›Full record

Trial reportBlood2015

Cladribine and cytarabine in refractory multisystem Langerhans cell histiocytosis: results of an international phase 2 study.

Jean Donadieu, Frederic Bernard, Max van Noesel, Mohamed Barkaoui, Odile Bardet, Rosella Mura, Maurizio Arico, Christophe Piguet, Virginie Gandemer, Corinne Armari Alla and 7 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 73 papers.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed
6.6field-weighted citation impact, top 3% 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.

NCT04773366 phase3unknown statusnot on this mapstarted 2018, after this paper: background citation

A Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol

TypeinterventionalSponsorShanghai Children's Medical CenterRan2018 to 2026Enrolled200ConditionsLangerhans Cell HistiocytosisArmsPrednisone+Cytarabine+vincristine, Prednisone+Cytarabine+vincristine+Mercaptopurine, Prednisone+vincristine+Mercaptopurine, Prednisone+vincristine, Local therapy
NCT07022834 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Real-world Investigation of the Combination of Darafenib or Trametinib and Clofarabine in the Treatment of High-risk, Recurrent, or Refractory Pediatric Patients With Langerhans Cell Histiocytosis.

TypeinterventionalSponsorWest China Second University HospitalRan2025 to 2030Enrolled20ConditionsLangerhans Cell Histiocytosis (LCH)ArmsDabrafenib or Trametinib and Clofarabine
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 165 citations in OpenAlex.

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  8. Cell-free BRAFHaematologica · 2026
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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 6 countries.

Jean DonadieuService d'Hémato-Oncologie Pédiatrique, Hopital Trousseau, Paris Registre des Histiocytoses Centre de Référence des Histiocytoses, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France;ORCID http://orcid.org/0000-0002-4485-146X
Frederic BernardHémato Oncologie Pédiatrique, Centre Hospitalier Universitaire (CHU) de Montpellier, Montpellier, France;
Max van NoeselDepartment of Pediatric Hematology Oncology, Erasmus MC-Sophia's Children's Hospital, Rotterdam, The Netherlands;
Mohamed BarkaouiService d'Hémato-Oncologie Pédiatrique, Hopital Trousseau, Paris Registre des Histiocytoses Centre de Référence des Histiocytoses, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France;
Odile BardetDirection Recherche et Innovation, Centre Hospitalier Régional Universitaire (CHRU) Montpellier-Centre Administratif André Benech, Montpellier, France;
Rosella MuraPediatric Hematology Oncology, Ospedale microcetemico, Cagliari, Italy;
Maurizio AricoPediatric Hematology Oncology, Azienda Sanitaria Provinciale, Ragusa, Italy;
Christophe PiguetPediatric Hémato Oncology, CHU, Limoges, France;
Virginie GandemerPediatric Hémato Oncology, CHU, Rennes, France;
Corinne Armari AllaPediatric Hémato Oncology, CHU, Grenoble, France;
Niels ClausenPediatric Hematology Oncology, Universitets Hospital of Aarhus at Skejby, Aarhus, Denmark;
Eric JeziorskiHémato Oncologie Pédiatrique, Centre Hospitalier Universitaire (CHU) de Montpellier, Montpellier, France;
Anne LambilliotePediatric Hémato Oncology, Hopital Jean De Flandre, CHU, Lille, France;
Sheila WeitzmanPediatric Hematology Oncology, The Hospital for Sick Children, Toronto, ON, Canada;
Jan Inge HenterDepartment of Women's and Children's Health, Karolinska Institute, Karolinska Univeristy Hospital, Stockholm Sweden; and.
Cor Van Den BosDepartment of Pediatric Oncology, Emma Children's Hospital/Academic Medical Center, Amsterdam, The Netherlands.
Salvage Group of the Histiocyte Society
Centre Hospitalier Universitaire de Montpellier · FRSorbonne Université · FRAarhus University Hospital · DKAgenzia Regionale Sanitaria della Puglia · ITAmsterdam UMC Location University of Amsterdam · NLCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Limoges · FRCentre Hospitalier Universitaire de Rennes · FRErasmus MC - Sophia Children’s Hospital · NLHôpital Jeanne de Flandre · FRHospital for Sick Children · CAKarolinska University Hospital · SEOspedale Microcitemico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An international phase 2 study combining cladribine and cytarabine (Ara-C) was initiated for patients with refractory, risk-organ-positive Langerhans cell histiocytosis (LCH) in 2005. The protocol, comprising at least two 5-day courses of Ara-C (1 g/m(2) per day) plus cladribine (9 mg/m(2) per day) followed by maintenance therapy, was administered to 27 patients (median age at diagnosis, 0.7 years; median follow-up, 5.3 years). At inclusion, all patients were refractory after at least 1 course of vinblastine (VBL) plus corticosteroid, all had liver and spleen involvement, and 25 patients had hematologic cytopenia. After 2 courses, disease status was nonactive (n = 2), better (n = 23), or stable (n = 2), with an overall response rate of 92%. Median disease activity scores decreased from 12 at the start of therapy to 3 after 2 courses (P < .0001). During maintenance therapy, 4 patients experienced reactivation in risk organs. There were 4 deaths; 2 were related to therapy toxicity and 2 were related to reactivation. All patients experienced severe toxicity, with World Health Organization grade 4 hematologic toxicity and 6 documented severe infections. The overall 5-year survival rate was 85% (95% confidence interval, 65.2%-94.2%). Thus, the combination of cladribine/Ara-C is effective therapy for refractory multisystem LCH but is associated with high toxicity.

Indexed as

Antineoplastic AgentsChild, PreschoolCladribineCytarabineFemaleHistiocytosis, Langerhans-CellHumansImmunosuppressive AgentsInfantLangerhans CellsLiverMaleRecurrenceSpleenSurvival AnalysisSurvival RateAntineoplastic AgentsCladribineCytarabineImmunosuppressive AgentsVinblastine

Identifiers

PMID26194764
PMCPMC4624454
OpenAlexW992317070

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.