Evidence map›Paper›PMID 39951620›Full record

Trial reportBlood advances2025

Phase 1 trial of durvalumab (anti-PD-L1) combined with lenalidomide in relapsed/refractory cutaneous T-cell lymphoma.

Christiane Querfeld, Joycelynne Palmer, Zhen Han, Xiwei Wu, Yate-Ching Yuan, Min-Hsuan Chen, Chingyu Su, Ni-Chun Tsai, D Lynne Smith, Samantha N Hammond and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03011814 (A Phase 1/2 Trial of Durvalumab), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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.

NCT03011814 phase1 / phase2recruitingnot on this map

A Phase 1/2 Trial of Durvalumab (MEDI4736) When Given as a Single Agent or in Combination With Lenalidomide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma, Including Cutaneous T-cell Lymphoma

TypeinterventionalSponsorCity of Hope Medical CenterRan2017 to 2030Enrolled78ConditionsFolliculotropic Mycosis Fungoides, Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides, Refractory Cutaneous T-Cell Non-Hodgkin LymphomaArmsDurvalumab, Laboratory Biomarker Analysis, Lenalidomide
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. 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

15 authors.

Christiane QuerfeldDivision of Dermatology, City of Hope, Duarte, CA.ORCID 0000-0001-9698-5809
Joycelynne PalmerBeckman Research Institute, City of Hope, Duarte, CA.ORCID 0000-0001-6480-7557
Zhen HanDepartment of Pathology, City of Hope, Duarte, CA.ORCID 0000-0002-9230-2270
Xiwei WuBeckman Research Institute, City of Hope, Duarte, CA.ORCID 0000-0002-7071-1671
Yate-Ching YuanBeckman Research Institute, City of Hope, Duarte, CA.ORCID 0000-0002-3698-9784
Min-Hsuan ChenBeckman Research Institute, City of Hope, Duarte, CA.
Chingyu SuDepartment of Pathology, City of Hope, Duarte, CA.ORCID 0000-0001-8354-8503
Ni-Chun TsaiBeckman Research Institute, City of Hope, Duarte, CA.
D Lynne SmithDepartment of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.ORCID 0000-0003-2400-659X
Samantha N HammondBeckman Research Institute, City of Hope, Duarte, CA.
Liliana CrisanDivision of Dermatology, City of Hope, Duarte, CA.
Joo Y SongDepartment of Pathology, City of Hope, Duarte, CA.ORCID 0000-0003-3497-2513
Raju PillaiDepartment of Pathology, City of Hope, Duarte, CA.ORCID 0000-0001-8553-4252
Steven T RosenDepartment of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.ORCID 0000-0002-8818-7724
Jasmine ZainDepartment of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.ORCID 0000-0003-4308-629X

Funding

Cutaneous T cell lymphoma: a paradigm for dissecting susceptibility and resistance to checkpoint inhibition therapyR01CA229510 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI QUERFELD, CHRISTIANE · 2019 to 2023
$2.8M
NCI NIH HHS R01 CA229510
6 · The paper itself

Abstract

abstractSelective targeting of the functionally exhausted malignant T cells in cutaneous T-cell lymphoma (CTCL) and distinct cells within the tumor microenvironment (TME) via programmed cell death 1/programmed cell death ligand 1 blockade (durvalumab) may restore an antitumor immune response. The oral immunomodulator lenalidomide, which has activity in CTCL, may enhance durvalumab immune checkpoint blockade. Our phase 1/2 clinical trial of durvalumab and lenalidomide in patients with refractory/advanced CTCL sought to assess the safety and tolerability and to identify the maximum tolerated dose and recommended phase 2 dose (RP2D) of lenalidomide plus fixed-dose durvalumab. Secondary and tertiary objectives were to investigate the efficacy and effects on the TME. Thirteen patients were evaluable for toxicities and 12 for dose decisions and response. No serious adverse events (AEs) or dose-limiting toxicities (DLTs) were observed during cycles 1 to 3 (DLT evaluation period), and dose level 3 was identified as the RP2D. The most frequent AEs were tumor flare, fatigue, neutropenia, and leukopenia. Three patients developed grade 1 or 2 autoimmune thyroiditis that resolved with treatment. Best overall and skin response rates were 58.3% (95% confidence interval (95% CI), 27.7-84.8%) and 75% (95% CI: 42.8-94.5%), respectively. The median cycles of treatment were 11, and the median duration of response was 25.5 months. The combination showed clinical activity with 7 partial responses and 4 stable disease. Potentially predictive immune signatures were downregulation of -α signaling via NF-κB, interferon gamma, and phosphoinositide 3 kinase-AKT-mammalian target of rapamycin signaling pathways in responders and upregulation of MYC targets and proinflammatory pathways in nonresponders. Profiling of immune cell compositions revealed changes in individual immune cell clusters based on treatment response. This trial was registered at www.ClinicalTrials.gov as #NCT03011814.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsLenalidomideLymphoma, T-Cell, CutaneousAdultAgedB7-H1 AntigenFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, MonoclonalB7-H1 AntigenCD274 protein, humandurvalumabLenalidomide

Identifiers

PMID39951620
PMCPMC12088755

What OpenQuestion holds

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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.