Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

Completed

• Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma

• Registration Number: NCT03356678
• Lead Sponsor: Samsung Medical Center

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, 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.

1. Age, sex, nationality, ethnicity

2. 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

3. Dose and schedule of pralatrexate, start date, last treatment date, other treatment modalities

Study Timeline

• Study Start: 2016-09-23
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2017-07-19
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-23
• Last Update Submitted: 2017-11-23
• Study First Posted: 2017-11-29
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

15. 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

  2. Aggressive NK-cell leukemia

  3. T-cell prolymphocytic leukemia

  4. T-cell large granular lymphocytic leukemia

  5. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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.

Trial Locations

Locations (2)

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Seoul, Korea, Republic Of, Korea, Republic of