Evidence map›Paper›PMID 37327113›Full record

Trial reportBlood advances2023

Multicenter phase 2 study of romidepsin plus lenalidomide for previously untreated peripheral T-cell lymphoma.

Jia Ruan, Jasmine Zain, Brett Palmer, Borko Jovanovic, Xinlei Mi, Alok Swaroop, Jane N Winter, Leo I Gordon, Reem Karmali, Jonathan Moreira and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood advances, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02232516 (Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
7.7field-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.

NCT02232516 phase2completednot on this map

Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL

TypeinterventionalSponsorNorthwestern UniversityRan2015 to 2024Enrolled30ConditionsAdult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell LymphomaArmsromidepsin, lenalidomide, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
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  7. Article
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  11. Article
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  13. Review
  14. Getting the right combination to break the epigenetic code.Nature reviews. Clinical oncology · 2025
    Review
  15. Review
  16. Review
  17. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  18. Article
  19. Failing Forward in Peripheral T-Cell Lymphoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  20. 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

12 authors at 3 institutions in 1 country.

Jia RuanWeill Cornell Medicine and New York Presbyterian Hospital, New York, NY.
Jasmine ZainCity of Hope Comprehensive Cancer Center, Duarte, CA.ORCID 0000-0003-4308-629X
Brett PalmerRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.
Borko JovanovicDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Xinlei MiDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Alok SwaroopRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0003-0317-6688
Jane N WinterRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.
Leo I GordonRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0003-1666-7064
Reem KarmaliRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0003-0984-4376
Jonathan MoreiraRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0009-0001-9749-7599
Adam M PetrichDaiichi Sankyo, Basking Ridge, NJ.
Barbara ProRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL.
Northwestern University · USCity of Hope · USNewYork–Presbyterian Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Peripheral T-cell lymphomas (PTCLs) are associated with poor prognosis when treated with cytotoxic chemotherapy. We report the findings of a phase 2 study evaluating a chemotherapy-free combination of romidepsin plus lenalidomide as initial treatment for patients with PTCL who were aged >60 years or noncandidates for chemotherapy. Treatment was initiated with romidepsin 10 mg/m2 IV on days 1, 8, and 15 and lenalidomide 25 mg taken orally from days 1 to 21 of 28-day cycle for up to 1 year. The primary objective was overall response rate (ORR). Secondary objectives included safety and survival. The study enrolled 29 patients with a median age of 75 years, including 16 (55%) angioimmunoblastic T-cell lymphoma (AITL), 10 (34%) PTCL- not otherwise specified, 2 ATLL, and 1 EATL. Grade 3 to 4 hematologic toxicities included neutropenia (45%), thrombocytopenia (34%), and anemia (28%). Grade 3 to 4 nonhematologic toxicities included hyponatremia (45%), hypertension (38%), hypoalbuminemia (24%), fatigue (17%), hyperglycemia (14%), hypokalemia (14%), dehydration (10%), and infection (10%). At median follow-up of 15.7 months, 23 patients were evaluable and received a median treatment of 6 cycles. The ORR was 65.2% with complete response (CR) at 26.1%, including 78.6% ORR and 35.7% CR for AITL. Median duration of response was 10.7 months, with 27.1 months for patients achieving CR. The estimated 2-year progression-free survival was 31.5%, and 2-year overall survival was 49.5%. This study provides the first demonstration that the biologic combination of romidepsin and lenalidomide is feasible and effective as initial therapy for PTCL and warrants further evaluation. This trial was registered at www.clinicaltrials.gov as #NCT02232516.

Indexed as

DepsipeptidesLymphoma, T-Cell, PeripheralAgedHumansLenalidomideTreatment OutcomeDepsipeptidesLenalidomideromidepsin

Identifiers

PMID37327113
PMCPMC10561000
OpenAlexW4380989962

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.