Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
All patients who satisfy the inclusion criteria for this study in each participating institution will be included. Considering the number of participating centers in Korea, Latin America (Mexico, Colombia), and Europe (Switzerland, Israel), the expected number of patients is 50.
This research involves only the collection and analysis of existing data, documents, and records. The information will be recorded by the investigators on a CRF in a way that the subjects cannot be identified directly or through identifiers linked to the subjects. Thus, this study should be reviewed and approved by the Institutional Review Board of each participating institute, and exemption from additional written informed consent should be applied.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pralatrexate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) including complete remission (CR) and partial remission (PR) | retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records | This is a restrospective study. Data collection and analysis will be done for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records | This is a restrospective study. Data collection and analysis will be done for 6 months. |
| Overall survival (OS) |
Not provided
Inclusion Criteria:
- 1. Histologically confirmed peripheral T-cell lymphoma according to following inclusion criteria of subtypes according to the 2016 revision of the World Health Organization classification of lymphoid neoplasm
4. Patients treated with pralatrexate 30mg/m2 once a week for 6 weeks as part of a 7-week cycle. However, modified dose and/or schedule allowed.
Exclusion Criteria:
1. Histologically confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes
Not provided
Not provided
Not provided
All patients who satisfy the inclusion criteria for this study in each participating institution will be included. Considering the number of participating centers in Korea, Latin America (Mexico, Colombia), and Europe (Switzerland, Israel), the expected number of patients is 50.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul, Korea, Republic of | 135-710 | South Korea | ||
| 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C418863 | 10-propargyl-10-deazaaminopterin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records |
| This is a restrospective study. Data collection and analysis will be done for 6 months. |
| Duration of response (DoR) | retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records | This is a restrospective study. Data collection and analysis will be done for 6 months. |
| Toxicity | This study will investigate the number of participants with grade 3-4 neutropenia, grade 3-4 thrombocytopenia, grade 3-4 anemia and grade 4 febrile neutropenia according to CTCAE v4.0. This study will also investigate the number of participants with nausea, anorexia, constipation, diarrhea, peirpheral neuropathy, and skin rash that are related pralatrexate treatment according to CTCAE v4.0. | This is a restrospective study. Data collection and analysis will be done for 6 months. |
| Tolerability | This study will investigate the dose intensity of pralatrexate based in information from patient medical records. | This is a restrospective study. Data collection and analysis will be done for 6 months. |
| Seoul |
| 06351 |
| South Korea |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |