Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

Relapsed or Refractory Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356678
• Other study ID #: 2016-09-090
• Status: Completed
• Phase: N/A
• First received: July 19, 2017
• Last updated: November 23, 2017
• Start date: September 23, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Relapsed or Refractory Peripheral T-cell Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Seoul, Korea, Republic Of

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.