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Trial record 7 of 35 for:    pralatrexate AND cells

Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356678
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, 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

Condition or disease Intervention/treatment
Relapsed or Refractory Peripheral T-cell Lymphoma 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

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma: a Multicenter, Multinational Retrospective Analysis
Actual Study Start Date : September 23, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma


Intervention Details:
  • Drug: Pralatrexate
    • 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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356678


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Won Seog Kim, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03356678     History of Changes
Other Study ID Numbers: 2016-09-090
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Aminopterin
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action