Evidence map›Paper›PMID 21821712›Full record

Trial reportBlood2011

Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia.

Farhad Ravandi, Susan O'Brien, Jeffrey Jorgensen, Sherry Pierce, Stefan Faderl, Alessandra Ferrajoli, Charles Koller, Pramoda Challagundla, Sergernne York, Mark Brandt and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00412594 (Phase II Study of 2-Chlorodeoxyadenosine), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
4.7field-weighted citation impact, top 5% 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.

NCT00412594 phase2recruitingnot on this map

Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2004 to 2027Enrolled150ConditionsHairy Cell Leukemia, Recurrent Hairy Cell LeukemiaArmsCladribine, Laboratory Biomarker Analysis, Rituximab
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 123 citations in OpenAlex.

  1. Trial
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  3. Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
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  5. Observational
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  7. Review
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  12. Review
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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 1 institution in 1 country.

Farhad RavandiDepartment of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA. fravandi@mdanderson.org
Susan O'Brien
Jeffrey Jorgensen
Sherry Pierce
Stefan Faderl
Alessandra Ferrajoli
Charles Koller
Pramoda Challagundla
Sergernne York
Mark Brandt
Rajyalakshmi Luthra
Jan Burger
Deborah Thomas
Michael Keating
Hagop Kantarjian
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

We conducted this study to determine the feasibility and safety of cladribine followed by rituximab in patients with hairy cell leukemia including the vari-ant form (HCLv). Cladribine 5.6 mg/m² given IV over 2 hours daily for 5 days was followed ∼ 1 month later with rituximab 375 mg/m² IV weekly for 8 weeks. Responses were recorded and BM minimal residual disease (MRD) was evaluated after the completion of rituximab. Thirty-six patients have been treated including 5 with HCLv. Median age was 57 years (range, 37-89). All patients (100%) have achieved complete response (CR), defined as presence of no hairy cells in BM and blood with normalization of counts (absolute neutrophil count [ANC]> 1.5 × 10⁹/L, hemoglobin [Hgb] > 12.0 g/dL, platelets [PLT] > 100 × 10⁹/L), as well as resolution of splenomegaly. There were no grade 3 or 4 nonhematologic adverse events directly related to the treatment. Only 1 patient (with HCLv) has relapsed; median CR duration has not been reached (range,1+-63+ months). Three patients with HCLv died including 1 with relapsed disease and 2 from unrelated malignancies. Median survival duration has not been reached (range, 2+-64+ months). Treatment with cladribine followed by rituximab is effective tk;4and may increase CR rate. This study was registered at www.clinicaltrials.gov as NCT00412594.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic AgentsCladribineFemaleFollow-Up StudiesHumansImmunosuppressive AgentsLeukemia, Hairy CellMaleMiddle AgedNeoplasm, ResidualRituximabTreatment OutcomeAntibodies, Monoclonal, Murine-DerivedAntineoplastic AgentsCladribineImmunosuppressive AgentsRituximab

Identifiers

PMID21821712
PMCPMC4081440
OpenAlexW2095109014

What OpenQuestion holds

Textmetadata
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.