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Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

NCT ID: NCT03356678

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-23

Study Completion Date

2017-06-30

Brief Summary

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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

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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

Conditions

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Relapsed or Refractory Peripheral T-cell Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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. 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Seog Kim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Seoul, Korea, Republic of, South Korea

Site Status

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2016-09-090

Identifier Type: -

Identifier Source: org_study_id