Peripheral T-cell lymphoma
Conditions
Interventions
None listed
Sponsors
University of Fukui Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cases with pathologic diagnosis of peripheral T-cell lymphoma by tissue biopsy. If possible, the diagnosis should be made on a post-relapse biopsy; however, if the relapse occurred at a site that is difficult to biopsy, the pathologic diagnosis at the time of initial disease is acceptable. The following pathologic types according to the WHO classification of Tumors of Hematopoietic and Lymphoid Tissues 2017 edition are included. PTCL, NOS AITL Follicular T-cell lymphoma Nodal peripheral T-cell lymphoma with T follicular helper phenotype ALK+ ALCL ALK- ALCL 2) Patients with relapsed/refractory disease who have received at least one regimen of prior therapy after diagnosis. (Do not include patients treated with radiation alone or steroids alone.) 3) Patients must be at least 20 years old at the time of consent. 4) Eastern Cooperative Oncology Group (ECOG)-performance status (PS) of 0 to 3 at the time of enrollment. 5) Cases with more than one evaluable lesion (measurable in two orthogonal directions on CT and with a maximum tumor diameter of 1.5 cm or greater) 6) Written consent for participation in this study is obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with QT prolongation on 12-lead ECG (for QT prolongation, QT > 450 msec for males and QT > 470 msec for females; the Fridericia correction formula: QTc=(QT interval)/(RR interval)1/3 should be used to calculate the QT interval). 2) Complicated severe infection. 3) Pregnant or possibly pregnant women. 4) Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study. 5) Patients with active multiple cancers (including synchronous multiple cancers, multiple cancers, and iatrogenic multiple cancers with a disease-free interval of less than 5 years. However, even if the disease-free period is less than 5 years, stage I prostate cancer and the following carcinomas that have been completely resected shall not be included in active overlapping or multiple cancers. Gastric cancer (adenocarcinoma): stage 0-I; Colon cancer (adenocarcinoma): stage 0-I; Rectal cancer (adenocarcinoma): stage 0-I; Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basal cell carcinoma): stage 0; Breast cancer (noninvasive ductal carcinoma of breast, noninvasive lobular carcinoma): stage 0; Breast cancer (invasive ductal carcinoma of breast, invasive lobular carcinoma, Paget's disease): stage 0-IIA; Uterine cancer (endometrial adenocarcinoma Stage I), Prostate cancer (adenocarcinoma): Stage I-II, Cervical cancer (squamous cell carcinoma): Stage 0, Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage I-III, Renal cell carcinoma (light-displicated renal cell carcinoma, anaplastic renal cell carcinoma): Stage I) 6) Patients with known hypersensitivity to any component of darinaparsin and those who have received darinaparsin in the past. 7) Cases in which the principal investigator or research coordinator determines that the patient is not appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of treatment discontinuation due to adverse events other than vascular pain by the completion of three treatment cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Percentage of patients who shifted from peripheral vascular administration to central venous administration due to vascular pain when administered via peripheral vessels (2)Numerical rating scale (NRS) for vascular pain when administered via peripheral vessels (3)Correlation between metabolic tumor volume* (PET scan) and response rate (4)overall response rate:ORR (5)complete response rate:CRR (6)disease control rate:DCR (7)progression-free survival:PFS (8)overall survival:OS (9)duration of response:DOR (10)time to response:TTR (11)Response rate by histological type, various survival indices(PFS, OS, DOR) | — |
Countries
Japan
Contacts
Public ContactEiju Negoro
University of Fukui Hospital Department of Hematology and Oncology
Outcome results
None listed