Evidence map›Paper›PMID 32958702›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Early Intervention with Lenalidomide in Patients with High-risk Chronic Lymphocytic Leukemia.

Shanmugapriya Thangavadivel, Qiuhong Zhao, Narendranath Epperla, Lindsey Rike, Xiaokui Mo, Mohamed Badawi, Darlene M Bystry, Mitch A Phelps, Leslie A Andritsos, Kerry A Rogers and 4 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 37% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Can Immunocompetence Be Restored in Chronic Lymphocytic Leukemia?Hematology/oncology clinics of North America · 2021
    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

14 authors at 2 institutions in 1 country.

Shanmugapriya ThangavadivelDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.ORCID 0000-0001-9542-9050
Qiuhong ZhaoDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Narendranath EpperlaDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Lindsey RikeDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Xiaokui MoDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Mohamed BadawiDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Darlene M BystryDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Mitch A PhelpsDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.ORCID 0000-0002-1615-5280
Leslie A AndritsosDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Kerry A RogersDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.ORCID 0000-0001-5748-7874
Jeffrey JonesDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Jennifer A WoyachDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
John C ByrdDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio. farrukh.awan@utsouthwestern.edu john.byrd@osumc.edu.
Farrukh T AwanHarold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas. farrukh.awan@utsouthwestern.edu john.byrd@osumc.edu.ORCID 0000-0003-1813-9812
The Ohio State University · USThe University of Texas Southwestern Medical Center · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
Targeted Therapy for LeukemiaR35CA197734 · NCI · UNIVERSITY OF CINCINNATI · PI BYRD, JOHN C. · 2015 to 2021
$6.6M
NCI NIH HHS P30 CA016058NCI NIH HHS R35 CA197734NCI NIH HHS UM1 CA186712
6 · The paper itself

Abstract

purposeInfectious complications constitute a leading cause of morbidity and mortality in chronic lymphocytic leukemia (CLL). Patients respond poorly to vaccines, particularly pneumococcal polysaccharide and influenza vaccines. In addition, patients with genetically high-risk disease are at increased risk for early disease progression and death. Lenalidomide, an oral immunomodulatory agent with demonstrated clinical activity in CLL, can potentially restore immune system dysfunction associated with CLL while improving disease outcomes. PATIENTS AND

methodsPhase II study randomized 49 patients with genetically high-risk CLL or small lymphocytic lymphoma [SLL; defined as unmutated Ig heavy chain variable region, deletion(17p) or (11q), and/or complex abnormal karyotype], to receive lenalidomide either concurrent (arm A) or sequential to (arm B) two doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13) administered 2 months apart, in patients not meeting International Workshop on Chronic Lymphocytic Leukemia treatment criteria.

resultsFour serotypes (3, 4, 5, 6B) achieved the additional seroprotection definition of a fourfold increase in arm A, and six serotypes (3, 4, 5, 6B, 19A, 19F) in arm B. All patients achieved the defined concentration of 0.35 μg/mL for at least one serotype tested. No significant difference was observed with the addition of lenalidomide. At median time on treatment of 3.6 years, median progression-free survival (PFS) was 5.8 years [95% confidence interval (CI), 3.1-not reached]. PFS at 1, 2, and 3 years was 85% (95% CI, 72-93), 79% (95% CI, 64-88), and 72% (95% CI, 57-83), respectively.

conclusionsLenalidomide is efficacious with manageable toxicities as an early intervention strategy in patients with high-risk CLL, but did not enhance humoral response to PCV13 vaccine.

Indexed as

AdultAgedAngiogenesis InhibitorsFemaleFollow-Up StudiesHumansLenalidomideLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPrognosisSurvival RateAngiogenesis InhibitorsLenalidomide

Identifiers

PMID32958702
PMCPMC8166407
OpenAlexW3087737297

What OpenQuestion holds

Textmetadata
LicenceTDM
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.