Clinical trial · Observational
Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma
Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma: a Multicenter, Multinational Retrospective Analysis
NCT03356678CI-TRIAL-00030555completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Peripheral T-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pralatrexate | Drug | Pralatrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall response rate (ORR) including complete remission (CR) and partial remission (PR)
- timeFrame
- This is a restrospective study. Data collection and analysis will be done for 6 months.
- description
- retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
Secondary outcomes (5)
- measure
- Progression-free survival (PFS)
- timeFrame
- This is a restrospective study. Data collection and analysis will be done for 6 months.
- description
- retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
- measure
- Overall survival (OS)
- timeFrame
- This is a restrospective study. Data collection and analysis will be done for 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 1. Adult T-cell leukemia/lymphoma 2. Angioimmunoblastic T-cell lymphoma 3. Anaplastic large cell lymphoma, ALK positive 4. Anaplastic large cell lymphoma, ALK negative 5. Peripheral T-cell lymphoma, NOS 6. Enteropathy-type intestinal lymphoma 7. Hepatosplenic T-cell lymphoma 8. Extranodal NK/T-cell lymphoma, nasal type 9. Subcutaneous panniculitis-like T-cell lymphoma 10. Transformed mycosis fungoides 11. Mycosis fungoides 12. Sézary syndrome 13. Primary cutaneous CD30+T-cell lymphoproliferative disorder (primary cutaneous anaplastic large cell lymphoma) 14. 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 Criteria: * 1\. Histologically confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes 1. Aggressive NK-cell leukemia 2. T-cell prolymphocytic leukemia 3. T-cell large granular lymphocytic leukemia 4. 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
References
Publications (0)
Data not yet available
No reference posted for this study.