Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma
Study Details
Study Description
Brief Summary
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
| Condition or Disease | Intervention/Treatment | Phase |
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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.
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Age, sex, nationality, ethnicity
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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
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Dose and schedule of pralatrexate, start date, last treatment date, other treatment modalities
Study Design
Outcome Measures
Primary Outcome Measures
- Overall response rate (ORR) including complete remission (CR) and partial remission (PR) [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
Secondary Outcome Measures
- Progression-free survival (PFS) [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
- Overall survival (OS) [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
- Duration of response (DoR) [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
- Toxicity [This is a restrospective study. Data collection and analysis will be done for 6 months.]
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.
- Tolerability [This is a restrospective study. Data collection and analysis will be done for 6 months.]
This study will investigate the dose intensity of pralatrexate based in information from patient medical records.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- 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
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Adult T-cell leukemia/lymphoma
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Angioimmunoblastic T-cell lymphoma
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Anaplastic large cell lymphoma, ALK positive
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Anaplastic large cell lymphoma, ALK negative
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Peripheral T-cell lymphoma, NOS
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Enteropathy-type intestinal lymphoma
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Hepatosplenic T-cell lymphoma
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Extranodal NK/T-cell lymphoma, nasal type
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Subcutaneous panniculitis-like T-cell lymphoma
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Transformed mycosis fungoides
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Mycosis fungoides
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Sézary syndrome
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Primary cutaneous CD30+T-cell lymphoproliferative disorder (primary cutaneous anaplastic large cell lymphoma)
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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.
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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:
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- Histologically confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes
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Aggressive NK-cell leukemia
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T-cell prolymphocytic leukemia
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T-cell large granular lymphocytic leukemia
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Seoul, Korea, Republic Of | Korea, Republic of | 135-710 |
| 2 | 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-09-090