Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

NCT03356678 | Completed

• 1 other identifier: 2016-09-090
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 2

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

Conditions

Relapsed or Refractory Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-free survival (PFS)

  This is a restrospective study. Data collection and analysis will be done for 6 months.

• Overall survival (OS)

  This is a restrospective study. Data collection and analysis will be done for 6 months.

• Duration of response (DoR)

  This is a restrospective study. Data collection and analysis will be done for 6 months.

• Toxicity

  This is a restrospective study. Data collection and analysis will be done for 6 months.

• Tolerability

  This is a restrospective study. Data collection and analysis will be done for 6 months.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, 135-710, South Korea

Location

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

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Interventions

10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: November 29, 2017
• Study Start: September 23, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

KR (2)