Evidence map›Paper›PMID 23270003›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Phase II study of lenalidomide and rituximab as salvage therapy for patients with relapsed or refractory chronic lymphocytic leukemia.

Xavier C Badoux, Michael J Keating, Sijin Wen, William G Wierda, Susan M O'Brien, Stefan Faderl, Rachel Sargent, Jan A Burger, Alessandra Ferrajoli

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06547944 (A Phase 1b Clinical Study of Lenalidomide in Combination With Zanubrutinib and Obinutuzumab), which is not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
13.0field-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.

NCT06547944 phase1active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 1b Clinical Study of Lenalidomide in Combination With Zanubrutinib and Obinutuzumab (ZGR) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) With Therapeutic Indications

TypeinterventionalSponsorInstitute of Hematology & Blood Diseases Hospital, ChinaRan2024 to 2026Enrolled30ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Newly DiagnosedArmsZanubrutinib, Lenalidomide, Obinutuzumab
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 153 citations in OpenAlex.

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  14. Immunomodulatory Drugs for the Treatment of B Cell Malignancies.International journal of molecular sciences · 2021
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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

9 authors at 1 institution in 1 country.

Xavier C BadouxThe University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Michael J Keating
Sijin Wen
William G Wierda
Susan M O'Brien
Stefan Faderl
Rachel Sargent
Jan A Burger
Alessandra Ferrajoli
The University of Texas MD Anderson Cancer Center · US

Funding

Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
NCI NIH HHS P01 CA081534
6 · The paper itself

Abstract

purposeLenalidomide is an immunomodulatory drug active as salvage therapy for chronic lymphocytic leukemia (CLL). We combined lenalidomide with rituximab to improve response rates in patients with relapsed or refractory CLL. PATIENTS AND

methodsFifty-nine adult patients (age 42 to 82 years) with relapsed or refractory CLL were enrolled onto a phase II study of lenalidomide and rituximab. Patients had received prior fludarabine-based therapy or chemoimmunotherapy. Rituximab (375 mg/m(2) intravenously) was administered weekly during cycle one and on day 1 of cycles three to 12. Lenalidomide was started on day 9 of cycle one at 10 mg orally and administered daily continuously. Each cycle was 28 days. Rituximab was administered for 12 cycles; lenalidomide could continue indefinitely if patients benefitted clinically.

resultsThe overall response rate was 66%, including 12% complete responses and 12% nodular partial remissions. Time to treatment failure was 17.4 months. Median overall survival has not been reached; estimated survival at 36 months is 71%. The most common grade 3 or 4 toxicity was neutropenia (73% of patients). Fourteen patients (24%) experienced a grade 3 to 4 infection or febrile episode. There was one episode of grade 3 tumor lysis; one patient experienced renal failure during the first cycle of therapy, and one venous thromboembolic event occurred during the study.

conclusionThe combination of lenalidomide and rituximab is active in patients with recurrent CLL and warrants further investigation.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleFeverHumansImmunologic FactorsInfectionsKaplan-Meier EstimateLenalidomideLeukemia, Lymphocytic, Chronic, B-CellAntibodies, Monoclonal, Murine-DerivedImmunologic FactorsLenalidomideRituximabThalidomide

Identifiers

PMID23270003
PMCPMC4878047
OpenAlexW2136597718

What OpenQuestion holds

Textmetadata
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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.