Evidence map›Paper›PMID 33653216›Full record

Trial reportLeukemia & lymphoma2021

Risk-adapted, ofatumumab-based chemoimmunotherapy and consolidation in treatment-naïve chronic lymphocytic leukemia: a phase 2 study.

Sanjal Desai, Clifton Mo, Erika M Gaglione, Constance M Yuan, Maryalice Stetler-Stevenson, Xin Tian, Irina Maric, Laura Wake, Mohammed Z Farooqui, Dennis C Drinkwater and 15 more

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

Trial report in Leukemia & lymphoma, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01145209 (A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 45% 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.

NCT01145209 phase2completednot on this map

A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2010 to 2023Enrolled32ConditionsSmall Lymphocytic Lymphoma, CLL (Chronic Lymphocytic Leukemia)ArmsFludarabine Phosphate, Ofatumumab, Cyclophosphamide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

25 authors at 7 institutions in 1 country.

Sanjal DesaiHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.ORCID 0000-0002-7892-2625
Clifton MoHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Erika M GaglioneHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Constance M YuanLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.
Maryalice Stetler-StevensonLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.
Xin TianOffice of Biostatistics Research, NHLBI, NIH, Bethesda, MD, USA.
Irina MaricDepartment of Laboratory Medicine, Clinical Research Center, NIH, Bethesda, MD, USA.
Laura WakeDepartment of Laboratory Medicine, Clinical Research Center, NIH, Bethesda, MD, USA.
Mohammed Z FarooquiHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Dennis C DrinkwaterWalter Reed National Military Medical Center, Bethesda, MD, USA.
Susan SotoHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Janet ValdezHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Thomas E HughesDepartment of Pharmacy, Clinical Research Center, NIH, Bethesda, MD, USA.
Pia NiermanHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Jennifer LotterHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Gerald E MartiHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Christopher PleyerHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.ORCID 0000-0002-9569-9605
Clare SunHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.ORCID 0000-0001-8498-4729
Jeanine SuperataHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Cydney NicholsHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Sarah E M HermanHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Margaret A LindorferDepartment of Biochemistry and Molecular Genetics, University of Virginia School of Medicine, Charlottesville, VA, USA.
Ronald P TaylorDepartment of Biochemistry and Molecular Genetics, University of Virginia School of Medicine, Charlottesville, VA, USA.
Adrian WiestnerHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Inhye E AhnHematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.ORCID 0000-0003-3717-287X
National Institutes of Health · USNational Institutes of Health Clinical Center · USNational Cancer Institute · USUniversity of Virginia · USCancer Research And Biostatistics · USMedStar Washington Hospital Center · USWalter Reed National Military Medical Center · US

Funding

Tumor microenvironment in CLL and MCL: pathogenesis, targets, and therapyZIAHL002346 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI WIESTNER, ADRIAN U · 2009 to 2025
$29.8M
Flow Cytometric Analysis of Benign and Malignant TumorsZICSC009372 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI WANG, HAO-WEI · 2009 to 2025
$29.6M
Immunotherapy of low grade lymphoid malignanciesZIAHL006070 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI WIESTNER, ADRIAN U · 2010 to 2025
$15.9M
Flow Cytometric Evaluation of BiomarkersZICBC011104 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WANG, HAO-WEI · 2009 to 2025
$8.6M
Bone Marrow Histopathological Changes in Neoplastic and Non-Neoplastic DiseasesZIACL090027 · CLC · CLINICAL CENTER · PI MARIC, IRINA · 2010 to 2025
$0k
Intramural NIH HHS ZIA HL006070
6 · The paper itself

Abstract

High-risk cytogenetics and minimal residual disease (MRD) after chemoimmunotherapy (CIT) predict unfavorable outcome in chronic lymphocytic leukemia (CLL). This phase 2 study investigated risk-adapted CIT in treatment-naïve CLL (NCT01145209). Patients with high-risk cytogenetics received induction with fludarabine, cyclophosphamide, and ofatumumab. Those without high-risk cytogenetics received fludarabine and ofatumumab. After induction, MRD positive (MRD+) patients received 4 doses of ofatumumab consolidation. MRD negative (MRD-) patients had no intervention. Of 28 evaluable for response, all responded to induction and 10 (36%) achieved MRD-. Two-year progression-free survival (PFS) was 71.4% (CI

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansImmunotherapyTreatment OutcomeAntibodies, Monoclonal, HumanizedofatumumabchemoimmunotherapyChronic lymphocytic leukemiaminimal residual diseaseofatumumabtrogocytosis

Identifiers

PMID33653216
PMCPMC9250410
OpenAlexW3135296454

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.