Evidence map›Paper›PMID 32800518›Full record

Trial reportClinical lymphoma, myeloma & leukemia2020

Phase 2 Study of Iodine-131 Tositumomab Plus Chemotherapy in Patients With Previously Untreated Mantle-Cell Lymphoma.

Andrew D Zelenetz, Leslie L Popplewell, Ariela Noy, Thierry J Horner, Thomas S Lin, Gerard Donnelly, George Sgouros, Ivelise Rijo, Chaitanya R Divgi

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00992992 (Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 50% 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.

NCT00992992 phase2completednot on this map

Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma

TypeinterventionalSponsorGlaxoSmithKlineRan2001 to 2013Enrolled25ConditionsLymphoma, Mantle-CellArmsTositumomab and Iodine I 131 Tositumomab followed by CHOP
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. 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

9 authors at 6 institutions in 1 country.

Andrew D ZelenetzDivision of Hematologic Oncology, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, NY. Electronic address: a-zelenetz@ski.mskcc.org.
Leslie L PopplewellCity of Hope Medical Center, Duarte, CA.
Ariela NoyDepartment of Medicine, Memorial Sloan-Kettering Cancer Center and Weill-Cornell Medical Center, New York, NY.
Thierry J HornerGlaxoSmithKline, Oncology Research and Development, Collegeville, PA.
Thomas S LinGlaxoSmithKline, Oncology Research and Development, Collegeville, PA.
Gerard DonnellyNorth Shore University Hospital, New York, NY.
George SgourosJohns Hopkins Hospital, Baltimore, MD.
Ivelise RijoDivision of Hematologic Oncology, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
Chaitanya R DivgiColumbia University, New York, NY.
Memorial Sloan Kettering Cancer Center · USGlaxoSmithKline (United States) · USCity Of Hope National Medical Center · USColumbia University · USJohns Hopkins Hospital · USNorth Shore University Hospital · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundMantle-cell lymphoma (MCL) is sensitive to radiotherapy, and the CD20 antigen is relatively highly expressed in MCL. Therefore, radioimmunotherapy using radiolabeled anti-CD20 monoclonal antibodies has the potential to treat MCL. The objective of this study was to investigate the efficacy, pharmacokinetics, and safety of tositumomab (TST) and iodine-131 tositumomab (I-131 TST) followed by 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with previously untreated MCL (ClinicalTrials.govNCT00022945). PATIENTS AND

methodsIn this phase 2 open-label study, patients received dosimetric (day 0: 450 mg TST, then 35 mg I-131 TST [5 mCi]) and therapeutic (between days 7 and 14: 450 mg TST, then an individualized dose of I-131 TST [65-75 cGy]) TST/I-131 TST, with CHOP treatment commencing approximately 13 weeks after the therapeutic dose. The primary end point was the MCL response rate to treatment; secondary end points included confirmed complete response rate and total body residence time.

resultsTwenty-six patients were enrolled, and 25 were included in the intent-to-treat population. The overall unconfirmed response rate was 84%, and the confirmed complete response rate was 44%. The median progression free-survival was 27.6 months. The median total body residence time was 94.5 hours. No new or unexpected safety signals were identified.

conclusionPatients with previously untreated MCL who received radioimmunotherapy with TST/I-131 TST followed by CHOP had a high response rate and a long duration of response, indicating that radioimmunotherapy is a therapeutic option in this patient population.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsFemaleHumansLymphoma, Mantle-CellMaleMiddle AgedProgression-Free SurvivalAntibodies, MonoclonalAntineoplastic Agentstositumomab I-131Anti-CD20CHOPMonoclonal antibodyRadioimmunotherapy

Identifiers

PMID32800518
PMCPMC10629362
OpenAlexW2943411441

What OpenQuestion holds

Textmetadata
LicenceTDM
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.