Status:
COMPLETED
Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Relapsed or Refractory Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
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
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, Colo...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 23 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03356678
Start Date
September 23 2016
End Date
June 30 2017
Last Update
November 29 2017
Active Locations (2)
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1
Samsung Medical Center
Seoul, Seoul, Korea, Republic of, South Korea, 135-710
2
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, South Korea, 06351