Evidence map›Paper›PMID 35074072›Full record

Trial reportThe Lancet. Oncology2022

Ibrutinib-rituximab followed by R-HCVAD as frontline treatment for young patients (≤65 years) with mantle cell lymphoma (WINDOW-1): a single-arm, phase 2 trial.

Michael L Wang, Preetesh Jain, Shuangtao Zhao, Hun Ju Lee, Loretta Nastoupil, Luis Fayad, Chi Young Ok, Rashmi Kanagal-Shamanna, Holly A Hill, Yixin Yao and 28 more

Open access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 2% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Evaluation of second-generation Bruton's tyrosine kinase inhibitors for the treatment of mantle cell lymphoma.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2025
    Observational
  12. Review
  13. Review
  14. Article
  15. Your chemo is no good here: management of high-risk MCL.Hematology. American Society of Hematology. Education Program · 2024
    Review
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  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors at 2 institutions in 1 country.

Michael L WangDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: miwang@mdanderson.org.
Preetesh JainDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shuangtao ZhaoDepartment of Genomic Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hun Ju LeeDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Loretta NastoupilDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Luis FayadDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Chi Young OkDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rashmi Kanagal-ShamannaDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Holly A HillDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yixin YaoDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Fredrick B HagemeisterDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jason R WestinDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nathan FowlerDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Felipe SamaniegoDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Raphael SteinerDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ranjit NairDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Swaminathan P IyerDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Lucy NavsariaDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Maria BadilloDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mantle Cell Research Group
Lei FengDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Huang XuelinDepartment of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Graciela M Nogueras GonzalezDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guofan XuDepartment of Nuclear Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nicolaus Wagner-BartakDepartment of Abdominal Imaging, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Selvi ThirumurthiDepartment of Gastroenterology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
David SantosDepartment of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guilin TangDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Pei LinDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sa A WangDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jeff JorgensenDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
C Cameron YinDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shaoying LiDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Keyur P PatelDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Francisco VegaDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
L Jeffery MedeirosDepartment of Hemato-Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Christopher R FlowersMantle Cell Research Group, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Linghua WangDepartment of Genomic Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA; MD Anderson Cancer Center UT Health Graduate School of Biomedical Sciences, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USThe University of Texas Health Science Center at Houston · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NovaSeq6000S10OD024977 · OD · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUFF, VICKI · 2018 to 2018
$995k
NCI NIH HHS P30 CA016672NIH HHS 1S10OD024977-01NIH HHS S10 OD024977
6 · The paper itself

Abstract

backgroundInduction with ibrutinib and rituximab provides an opportunity to minimise chemotherapy exposure, because upfront use of these targeted therapies could result in remission without chemotherapy and allow for consolidation with only four cycles of chemotherapy instead of the conventional eight. We aimed to determine the activity and safety of ibrutinib-rituximab induction followed by shortened chemoimmunotherapy (four cycles) with rituximab plus hyper-fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (R-HCVAD) alternating with methotrexate-cytarabine in previously untreated patients with mantle cell lymphoma.

methodsWe did a single-centre, single-arm, phase 2 trial in previously untreated patients with mantle cell lymphoma. Eligible patients were aged 65 years or younger and had serum bilirubin of less than 1·5 mg/dL, creatinine clearance of 30 mL/min or more, Eastern Cooperative Oncology Group performance status of 2 or less, and cardiac ejection fraction 50% or more by echocardiogram. Patients received 12 cycles of ibrutinib-rituximab induction (part A; oral ibrutinib 560 mg daily and intravenous rituximab 375 mg/m

findings131 patients were enrolled between June 12, 2015, and Dec 6, 2018. The median age was 56 years (IQR 49-60). 58 (50%) of 117 patients had high Ki-67 (≥30%). 129 (98%, 95% CI 95-100) of 131 patients had an overall response in part A. The most common grade 3-4 adverse events were lymphocytopenia (19 [14%] of 131), skin rash (16 [12%]), thrombocytopenia (12 [9%]), infections (11 [8%]), and fatigue (ten [8%]) in part A and lymphocytopenia (96 [73%]), leukocytopenia (42 [32%]), thrombocytopenia (40 [30%]), and neutropenia (26 [20%]) in part B. There was one on-study death, which was not deemed to be treatment-related.

interpretationInduction with ibrutinib-rituximab in the frontline treatment of young patients with mantle cell lymphoma is active and safe. This approach allowed minimisation of the number of chemotherapy cycles, thereby reducing the adverse events associated with chemotherapy. Newer trials bringing the next-generation Bruton's tyrosine kinase inhibitors into the frontline setting might obviate the need for chemotherapy altogether in patients with mantle cell lymphoma.

fundingPharmacyclics, Janssen.

Indexed as

Lymphoma, Mantle-CellLymphopeniaThrombocytopeniaAdenineAdultAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideCytarabineDoxorubicinHumansMethotrexateMiddle AgedPiperidinesRituximabTreatment OutcomeVincristineAdenineCyclophosphamideCytarabineDoxorubicinibrutinibMethotrexatePiperidinesRituximabVincristine

Identifiers

PMID35074072
PMCPMC11937933
OpenAlexW4206934925

What OpenQuestion holds

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Registered trials

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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.