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Completed

NCT Number: NCT03356678

Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Seoul, Seoul, Korea, Republic of, South Korea

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About this study

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.

  • Age, sex, nationality, ethnicity
  • 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
  • Dose and schedule of pralatrexate, start date, last treatment date, other treatment modalities

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.
  • 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
  • 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

Treatment and study plan

Pralatrexate

Drug
  • Patients treated with pralatrexate due to relapse or refractory disease after primary and/or salvage treatment. Relapse following an autologous stem cell transplant allowed.
  • 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.

Primary outcomes

  1. Overall response rate (ORR) including complete remission (CR) and partial remission (PR)

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    Time frame: 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

  2. Overall survival (OS)

    Time frame: 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

  3. Duration of response (DoR)

    Time frame: 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

  4. Toxicity

    Time frame: 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.

  5. Tolerability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma: a Multicenter, Multinational Retrospective Analysis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2017
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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