Condition
Peripheral T-Cell Lymphoma
Peripheral T-cell lymphoma is a group of uncommon cancers in which mature T cells, immune white blood cells, grow out of control in lymph nodes and other tissues. The evidence is strongest for romidepsin, a drug, and trials in people whose lymphoma had returned or resisted earlier therapy found about a quarter to nearly 40 percent responded, across major subtypes. Those studies were moderate in size, and most people did not respond.
Sources: PMID 24493070; PMID 27981793
- Updated
- How we grade
- 47 studies cited
- Supplements studied
- 0
- Medicines and peptides
- 1
- Graded outcomes
- 3
Prescription medicines and peptides studied, for context
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| Overall Response Rate (PTCL) Pivotal Phase 2 trial (n=130): ORR 25% with 15% CR/CRu. NCI multicenter study (n=47): ORR 38% with 17% CR. Responses seen across all major PTCL subtypes. Led to FDA approval June 2011. | Improves (the measure goes up) | Moderate effect | 12 studies | |||
Studies that measured overall response rate (ptcl) | ||||||
| Duration of Response (PTCL) Pivotal trial: Median DOR 28 months in responders. NCI trial: Median DOR 8.9 months (range 2-74 months). Durable responses possible in heavily pretreated patients (median 3 prior therapies). | Improves (the measure goes up) | Large effect | 7 studies | |||
Studies that measured duration of response (ptcl)
| ||||||
| Response by Prior Therapy Responses observed regardless of number or type of prior therapies. Patients with up to 11 prior treatments responded. 38% of patients had prior stem cell transplant and still achieved responses. | Improves (the measure goes up) | Moderate effect | 8 studies | |||
Studies that measured response by prior therapy
| ||||||
Key findings
- Overall Response Rate (PTCL)Improves (the measure goes up)
- Duration of Response (PTCL)Improves (the measure goes up)
- Response by Prior TherapyImproves (the measure goes up)
Studies cited
47 studies from PubMed
- The HDAC inhibitor romidepsin renders liver cancer vulnerable to RTK targeting and immunologically active.
- Acetylation-dependent regulation of core spliceosome modulates hepatocellular carcinoma cassette exons and sensitivity to PARP inhibitors.
- Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study.
- Duvelisib plus romidepsin in relapsed/refractory T cell lymphomas: a phase 1b/2a trial.
- Multicenter phase 2 study of romidepsin plus lenalidomide for previously untreated peripheral T-cell lymphoma.
- Romidepsin (FK228) improves the survival of allogeneic skin grafts through downregulating the production of donor-specific antibody via suppressing the IRE1α-XBP1 pathway.
- Organ-specific toxicity of romidepsin in patients with preexisting cardiovascular disease: a retrospective analysis.
- Romidepsin Treatment in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: A Systematic Review and Meta-Analysis.
- Effect of 3BNC117 and romidepsin on the HIV-1 reservoir in people taking suppressive antiretroviral therapy (ROADMAP): a randomised, open-label, phase 2A trial.
- Early intervention with 3BNC117 and romidepsin at antiretroviral treatment initiation in people with HIV-1: a phase 1b/2a, randomized trial.
- Romidepsin (FK228), A Histone Deacetylase Inhibitor and its Analogues in Cancer Chemotherapy.
- Romidepsin (FK228) regulates the expression of the immune checkpoint ligand PD-L1 and suppresses cellular immune functions in colon cancer.
- Tamoxifen enhances romidepsin-induced apoptosis in T-cell malignant cells via activation of FOXO1 signaling pathway.
- Romidepsin hepatocellular carcinoma suppression in mice is associated with deregulated gene expression of bone morphogenetic protein and Notch signaling pathway components.
- Romidepsin and metformin nanomaterials delivery on streptozocin for the treatment of Alzheimer's disease in animal model.
- Combined oral 5-azacytidine and romidepsin are highly effective in patients with PTCL: a multicenter phase 2 study.
- Romidepsin: A New Drug for the Treatment of Cutaneous T-Cell Lymphoma
- The Histone Deacetylase Inhibitor Romidepsin Spares Normal Tissues While Acting as an Effective Radiosensitizer in Bladder Tumors in Vivo.
- Deciphering the molecular effects of romidepsin on germ cell tumours: DHRS2 is involved in cell cycle arrest but not apoptosis or induction of romidepsin effectors.
- Romidepsin-associated cardiac toxicity and ECG changes: A case report and review of the literature.
- Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma
- Romidepsin induces G2/M phase arrest via Erk/cdc25C/cdc2/cyclinB pathway and apoptosis induction through JNK/c-Jun/caspase3 pathway in hepatocellular carcinoma cells.
- Review of bioanalytical assays for the quantitation of various HDAC inhibitors such as vorinostat, belinostat, panobinostat, romidepsin and chidamine.
- Nursing Roles in Cardiac Safety: Romidepsin in Patients With T-Cell Lymphoma.
- Cyclic depsipeptides as potential cancer therapeutics.
- Romidepsin targets multiple survival signaling pathways in malignant T cells.
- Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
- Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy
- Romidepsin for cutaneous T-cell lymphoma
- Romidepsin: a guide to its clinical use in cutaneous T-cell lymphoma.
- Romidepsin for cutaneous T-cell lymphoma.
- Romidepsin for previously treated patients with peripheral or aggressive T-cell lymphomas.
- Romidepsin: a histone deacetylase inhibitor for refractory cutaneous T-cell lymphoma.
- Targeted cancer therapy: giving histone deacetylase inhibitors all they need to succeed.
- Histone deacetylase inhibitors in the treatment of cancer: overview and perspectives.
- Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma
- Romidepsin (Istodax, NSC 630176, FR901228, FK228, depsipeptide): a natural product recently approved for cutaneous T-cell lymphoma
- Romidepsin: a new therapy for cutaneous T-cell lymphoma and a potential therapy for solid tumors
- Romidepsin (Istodax, NSC 630176, FR901228, FK228, depsipeptide): a natural product recently approved for cutaneous T-cell lymphoma.
- Therapeutic advances in cutaneous T-cell lymphoma.
- Romidepsin in the treatment of T-cell lymphoma: profile report.
- Epigenetics in cancer: what's the future?
- Romidepsin: a novel histone deacetylase inhibitor for cancer.
- Romidepsin (Istodax) for cutaneous T-cell lymphoma.
- Romidepsin: a new therapy for cutaneous T-cell lymphoma and a potential therapy for solid tumors.
- Phase 2 multicenter trial of the histone deacetylase inhibitor romidepsin in patients with relapsed or refractory cutaneous T-cell lymphoma
- Romidepsin for the treatment of cutaneous T-cell lymphoma.