Evidence map›Paper›PMID 29954415›Full record

Trial reportJournal of hematology & oncology2018

Multi-center phase II trial of bortezomib and rituximab maintenance combination therapy in patients with mantle cell lymphoma after consolidative autologous stem cell transplantation.

Robert W Chen, Joycelynne M Palmer, Sarah Tomassetti, Leslie L Popplewell, Jessica Alluin, Pritsana Chomchan, Auayporn P Nademanee, Tanya Siddiqi, Ni-Chun Tsai, Lu Chen and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01267812 (A Phase II Study of Weekly Maintenance Bortezomib and Rituximab in Mantle Cell Lymphoma Post Autologous Hematopoietic Cell Transplantation), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

NCT01267812 phase2completednot on this map

A Phase II Study of Weekly Maintenance Bortezomib and Rituximab in Mantle Cell Lymphoma Post Autologous Hematopoietic Cell Transplantation

TypeinterventionalSponsorCity of Hope Medical CenterRan2011 to 2020Enrolled23ConditionsContiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Stage I Mantle Cell LymphomaArmsbortezomib, rituximab, laboratory biomarker analysis, immunohistochemistry staining method, RNA analysis
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Advances in Molecular Biology and Targeted Therapy of Mantle Cell Lymphoma.International journal of molecular sciences · 2019
    Review
  6. Review
  7. Mantle cell lymphoma and its management: where are we now?Experimental hematology & oncology · 2019
    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

19 authors at 2 institutions in 1 country.

Robert W ChenDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA. rchen@coh.org.
Joycelynne M PalmerDepartment of Information Sciences, City of Hope National Medical Center, Duarte, CA, USA.
Sarah TomassettiDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
Leslie L PopplewellDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
Jessica AlluinDepartment of Molecular and Cellular Biology, Beckman Research Institute of the City of Hope National Medical Center, Duarte, CA, USA.
Pritsana ChomchanDepartment of Molecular and Cellular Biology, Beckman Research Institute of the City of Hope National Medical Center, Duarte, CA, USA.
Auayporn P NademaneeDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
Tanya SiddiqiDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
Ni-Chun TsaiDepartment of Information Sciences, City of Hope National Medical Center, Duarte, CA, USA.
Lu ChenDepartment of Information Sciences, City of Hope National Medical Center, Duarte, CA, USA.
Fay ZuoClinical Trial Office, City of Hope National Medical Center, Duarte, CA, USA.
Rosemarie AbaryClinical Trial Office, City of Hope National Medical Center, Duarte, CA, USA.
Ji-Lian CaiDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
Alex F HerreraDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
John J RossiDepartment of Molecular and Cellular Biology, Beckman Research Institute of the City of Hope National Medical Center, Duarte, CA, USA.
Steven T RosenJudy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope National Medical Center, Duarte, CA, USA.
Stephen J FormanDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA, 91010, USA.
Larry W KwakToni Stephenson Lymphoma Center, Department of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, USA.
Leona A HolmbergClinical Research Division, Fred Hutchinson Cancer Research Center, Department of Medicine, University of Washington, Seattle, WA, USA.
City Of Hope National Medical Center · USUniversity of Washington · US

Funding

Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
Transplant for Lymphoma:Therapy-Related LeukemiaP50CA107399 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI FORMAN, STEPHEN J, KWAK, LARRY W · 2004 to 2022
$35.5M
Oncology Research Career Development ProgramK12CA001727 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI MORTIMER, JOANNE E. · 1992 to 2024
$14.6M
NCI NIH HHS K12 CA001727NCI NIH HHS P30 CA033572NCI NIH HHS P50 CA107399
6 · The paper itself

Abstract

backgroundMantle cell lymphoma (MCL) is an aggressive and incurable lymphoma. Standard of care for younger patients with MCL is induction chemotherapy followed by autologous stem cell transplantation (auto-HCT). Rituximab maintenance after auto-HCT has been shown to improve progression-free survival (PFS) and overall survival (OS) in MCL. Bortezomib maintenance therapy has also been shown to be tolerable and feasible in this setting. However, the combination of bortezomib and rituximab as maintenance therapy post-auto-HCT has not been studied.

methodsWe conducted a multicenter, phase II trial of bortezomib given in combination with rituximab as maintenance in MCL patients after consolidative auto-HCT. Enrolled patients (n = 23) received bortezomib 1.3 mg/m

resultsWith a median follow-up of 35.9 months, the 2-year DFS probability was 90.2% (95% CI 66-97), and 2-year OS was 94.7% (95% CI 68-99). The most frequent grade 3/4 toxic events were neutropenia (in 74% of patients) and lymphopenia (in 35%). The incidence of peripheral neuropathy was 48% for grade 1, 9% for grade 2, and 0% for grade 3/4. We also examined the role of quantitative cyclin D1 (CCND1) mRNA in monitoring minimal residual disease.

conclusionCombined bortezomib and rituximab as maintenance therapy in MCL patients following auto-HCT is an active and well-tolerated regimen.

trial registrationClinicalTrials.gov NCT01267812 , registered Dec 29, 2010.

Indexed as

Antineoplastic AgentsBortezomibFemaleHematopoietic Stem Cell TransplantationHumansLymphoma, Mantle-CellMaleRituximabTransplantation, AutologousTransplantation ConditioningAntineoplastic AgentsBortezomibRituximabAuto-HCTBortezomibCCND1Mantle cell lymphomaMRDRituximab

Identifiers

PMID29954415
PMCPMC6022297
OpenAlexW2810404518

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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.