An observational study in Relapsed or Refractory Peripheral T-cell Lymphoma, sponsored by Samsung Medical Center. Completed at 2 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-29.
Sponsored by Samsung Medical Center · Observational
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.
372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.
This study's enrollment of 33 is below the median of 160 across 31 observational studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Lymphoma, T-Cell, Peripheral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Patients treated with pralatrexate due to relapse or refractory disease after primary and/or salvage treatment. Relapse following an autologous stem cell transplant allowed. * 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.
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
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Progression-free survival (PFS)
retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Overall survival (OS)
retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2016 to primary completion in Jun 2017, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lymphoma, T-Cell, Peripheral →