Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

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

Study Overview

• Status: Completed
• Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Pralatrexate

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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
  • Seoul, Korea, Republic Of
    • Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This is a restrospective study. Data collection and analysis will be done for 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records	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	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	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.	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.	This is a restrospective study. Data collection and analysis will be done for 6 months.

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2016
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (ACTUAL): November 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: 2016-09-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No