Trial reportJournal of hematology & oncology2016
A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients.
Trial report in Journal of hematology & oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01822886 (Phase IIa Study on the Role of Gemcitabine Plus Romidepsin), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled 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.
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.
Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Evaluation of the efficacy and safety of first-line therapies for peripheral T-cell lymphoma: a systematic review and network meta-analysis.Frontiers in oncology · 2026Pooled it
- Efficacy and safety of histone deacetylase inhibitors in peripheral T-cell lymphoma: a systematic review and meta-analysis on prospective clinical trials.Frontiers in oncology · 2023Pooled it
- Efficacy and Treatment-Related Adverse Events of Romidepsin in PTCL Clinical Studies: A Systematic Review and Meta-Analysis.Frontiers in medicine · 2021Pooled it
- Allogeneic hematopoietic cell transplantation in mature T- or NK-lymphomas: a phase II clinical trial.Nature communications · 2026Trial
- Safety and efficacy of tenalisib in combination with romidepsin in patients with relapsed/refractory T-cell lymphoma: results from a phase I/II open-label multicenter study.Haematologica · 2024Trial
- Synergistic anti-tumor activity of the mTOR inhibitor everolimus and gemcitabine for relapsed/refractory peripheral T cell lymphoma.Frontiers in immunology · 2025Article
- Novel clinical risk stratification and treatment strategies in relapsed/refractory peripheral T-cell lymphoma.Journal of hematology & oncology · 2024Review
- Phase II Trial of Romidepsin as Consolidation Therapy after Gemcitabine, Dexamethasone, and Cisplatin in Elderly Transplant-Ineligible Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma.Hematology reports · 2024Article
- Update on histone deacetylase inhibitors in peripheral T-cell lymphoma (PTCL).Clinical epigenetics · 2023Review
- Epigenetic targets in B- and T-cell lymphomas: latest developments.Therapeutic advances in hematology · 2023Review
- Use of ifosfamide, carboplatin and etoposide in combination with brentuximab vedotin or romidepsin based on CD30 positivity in relapsed/refractory peripheral T-cell lymphoma.Cancer reports (Hoboken, N.J.) · 2022Article
- Peripheral T-Cell Lymphomas: Therapeutic Approaches.Cancers · 2022Review
- The Status and Prospects of Epigenetics in the Treatment of Lymphoma.Frontiers in oncology · 2022Review
- Molecularly targeted therapies for relapsed and refractory peripheral T-cell lymphomas.Seminars in hematology · 2021Article
- Therapy of Peripheral T Cell Lymphoma: Focus on Nodal Subtypes.Current oncology reports · 2020Review
- Article
- Advances in targeted therapy for malignant lymphoma.Signal transduction and targeted therapy · 2020Review
- Histone Deacetylases (HDACs) Guided Novel Therapies for T-cell lymphomas.International journal of medical sciences · 2019Review
- Colonal monomorphic epitheliotropic intestinal T-cell lymphoma with novel phenotype of cytoplasmic CD3 expression.Journal of clinical and experimental hematopathology : JCEH · 2018Article
- Lymphoma associated hemophagocytic syndrome: A single-center retrospective study.Oncology letters · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %.
methodsA multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen.
resultsThe ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption.
conclusionsGEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes.
trial registrationThe trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886 .
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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.