Relapsed or Refractory Peripheral T-cell LymphomaNCT03356678
Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma
An observational study of Relapsed or Refractory Peripheral T-cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Peripheral T-cell Lymphoma
- What is being tested?
- Pralatrexate
- How many people
- 33 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Sep 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
- Adult T-cell leukemia/lymphoma
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma, ALK positive
- Anaplastic large cell lymphoma, ALK negative
- Peripheral T-cell lymphoma, NOS
Show all 16Show fewer
- Enteropathy-type intestinal lymphoma
- Hepatosplenic T-cell lymphoma
- Extranodal NK/T-cell lymphoma, nasal type
- Subcutaneous panniculitis-like T-cell lymphoma
- Transformed mycosis fungoides
- Mycosis fungoides
- Sézary syndrome
- Primary cutaneous CD30+T-cell lymphoproliferative disorder (primary cutaneous anaplastic large cell lymphoma)
- Primary cutaneous gamma-delta T-cell lymphoma 2. Age ≥ 18 years old 3. Patients treated with pralatrexate due to relapse or refractory disease after primary and/or salvage treatment. Relapse following an autologous stem cell transplant allowed.
- 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.
Who cannot join
- 1. Histologically confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes
- Aggressive NK-cell leukemia
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Primary cutaneous CD30+ T-cell lymphoproliferative disorders (lymphomatoid papulosis) 2. Patients with active/symptomatic central nervous system (CNS) involvement. 3. HIV-related lymphoma 4. Prior allogeneic stem cell transplant within 6 months. 5. Concurrent active or history of other malignancies. 6. Concurrent uncontrolled serious medical or psychiatric conditions
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, Seoul, Korea, Republic of, 135-710
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, 06351
About this study
Official title: Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma: a Multicenter, Multinational Retrospective Analysis
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Read the detailed description
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.
- Age, sex, nationality, ethnicity
- Ann Arbor stage, disease involved sites, number of extranodal involvement, serum LDH concentration, ECOG performance status, presence of B symptoms, regional lymph node involvement, International Prognostic Index, bone marrow invasion at the time of pralatrexate treatment
- Dose and schedule of pralatrexate, start date, last treatment date, other treatment modalities
- Being tested
- Pralatrexate
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PralatrexateDrug
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This is a restrospective study. Data collection and analysis will be done for 6 months.
Secondary outcomes (5)
Progression-free survival (PFS)
retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: This is a restrospective study. Data collection and analysis will be done for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start23 Sep 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356678
- Sponsor's protocol ID
- 2016-09-090
- Status last verified
- Nov 2017
- First submitted
- 19 Jul 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma: a Multicenter, Multinational Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03356678
- Acronym / sponsor ID
- 2016-09-090
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Detailed description
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.
- Age, sex, nationality, ethnicity
- Ann Arbor stage, disease involved sites, number of extranodal involvement, serum LDH concentration, ECOG performance status, presence of B symptoms, regional lymph node involvement, International Prognostic Index, bone marrow invasion at the time of pralatrexate treatment
- Dose and schedule of pralatrexate, start date, last treatment date, other treatment modalities
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- 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
- Adult T-cell leukemia/lymphoma
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma, ALK positive
- Anaplastic large cell lymphoma, ALK negative
Key exclusion criteria (5 listed)
- 1. Histologically confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pralatrexate* 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. | Drug | – |
Primary outcome
Overall response rate (ORR) including complete remission (CR) and partial remission (PR)
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
5 secondary outcomes
Progression-free survival (PFS)
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Overall survival (OS)
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Duration of response (DoR)
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Toxicity
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Tolerability
Time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Peripheral T-cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) including complete remission (CR) and partial remission (PR) (time frame: This is a restrospective study. Data collection and analysis will be done for 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.