Evidence map›Paper›PMID 35584865›Full record

Trial reportJournal for immunotherapy of cancer2022

Risk-adapted chemoimmunotherapy using brentuximab vedotin and rituximab in children, adolescents, and young adults with newly diagnosed Hodgkin's lymphoma: a phase II, non-randomized controlled trial.

Jessica Hochberg, Jaclyn Basso, Qiuhu Shi, Liana Klejmont, Allyson Flower, Kristina Bortfeld, Lauren Harrison, Carmella van de Ven, Chitti Moorthy, Humayun Islam and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIControlled Clinical Trial
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02398240 (A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

NCT02398240 phase2completednot on this map

A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma

TypeinterventionalSponsorMitchell CairoRan2015 to 2022Enrolled40ConditionsHodgkin LymphomaArmsBrentuximab Vedotin, Doxorubicin, Vincristine, Rituximab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Pediatric Hodgkin Lymphoma in Low- and Middle-Income Countries (LMICs). A Narrative Review.Mediterranean journal of hematology and infectious diseases · 2024
    Review
  7. Review
  8. Review
  9. 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

13 authors at 2 institutions in 1 country.

Jessica HochbergPediatrics, New York Medical College, Valhalla, New York, USA.
Jaclyn BassoPediatrics, New York Medical College, Valhalla, New York, USA.
Qiuhu ShiEpidemiology and Community Health, New York Medical College, Valhalla, NY, USA.
Liana KlejmontPediatrics, New York Medical College, Valhalla, New York, USA.
Allyson FlowerPediatrics, New York Medical College, Valhalla, New York, USA.
Kristina BortfeldPediatrics, New York Medical College, Valhalla, New York, USA.
Lauren HarrisonPediatrics, New York Medical College, Valhalla, New York, USA.
Carmella van de VenPediatrics, New York Medical College, Valhalla, New York, USA.
Chitti MoorthyRadiology, New York Medical College, Valhalla, New York, USA.
Humayun IslamPathology, New York Medical College, Valhalla, New York, USA.
Perry GerardRadiology, New York Medical College, Valhalla, New York, USA.
Stephan VossRadiology, Boston Children's Hospital, Boston, Massachusetts, USA.
Mitchell S CairoPediatrics, New York Medical College, Valhalla, New York, USA mitchell_cairo@nymc.edu.ORCID 0000-0002-2075-434X
New York Medical College · USBoston Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCure rates for Hodgkin's lymphoma are excellent, but excess short-term and long-term morbidities from treatment remain a concern. Immunotherapy targeting both tumor antigens and the immunosuppressive tumor microenvironment in children, adolescents, and young adults with Hodgkin's lymphoma may improve early response rates and eliminate toxic chemotherapy and radiation, thus minimizing toxicity. We conducted a phase II study to evaluate the safety and overall response rate of brentuximab vedotin and rituximab in combination with risk-adapted chemotherapy in children, adolescents, and young adults with newly diagnosed classic Hodgkin's lymphoma (cHL).

methodsThis is a prospective, phase II, non-randomized, risk-assigned study. Patients were treated and evaluated between 2012 and 2020. Eligible patients were aged ≥1 and ≤30 years old with advanced stage, intermediate-risk, and high-risk newly diagnosed cHL. Patients received four or six cycles of brentuximab vedotin (1.2 mg/kg), doxorubicin (25 mg/m

resultsThirty patients were enrolled, with a median age of 15 years (4-23). There were 18 intermediate-risk and 12 high-risk patients. Toxicities included grade III mucositis (3%), infusion reaction (3%), and peripheral neuropathy (6%). There was a 100% complete response rate on completion of chemoimmunotherapy. Eighteen patients (60%) achieved a rapid early response. Four patients (13%) required IFRT. The 5-year event-free and overall survival rates were 100%, with a median follow-up of 62 months (18-105).

conclusionsImmunotherapy with brentuximab vedotin, rituximab, and risk-adapted chemotherapy is safe in children, adolescents, and young adults with newly diagnosed cHL. We have demonstrated 100% complete response and 100% event-free and overall survival rates at a median 5-year follow-up, with a significant reduction in use of more toxic chemotherapy and IFRT. A larger cohort is required to confirm these preliminary findings. TRIAL REGISTRATION NUMBER: NCT02398240.

Indexed as

Hodgkin DiseaseImmunoconjugatesAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBrentuximab VedotinChildChild, PreschoolHumansImmunologic FactorsImmunotherapyNeoplasm Recurrence, LocalProspective StudiesRituximabTreatment OutcomeTumor MicroenvironmentBrentuximab VedotinImmunoconjugatesImmunologic FactorsRituximabDrug Therapy, CombinationHematologic NeoplasmsImmunotherapyPediatrics

Identifiers

PMID35584865
PMCPMC9119160
OpenAlexW4280524875

What OpenQuestion holds

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LicenceCC BY-NC
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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.