Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients
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|ClinicalTrials.gov Identifier: NCT02497131|
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphatic Diseases||Drug: Brentuximab Vedotin||Phase 2|
BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007).
Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) and PET scan will be performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with at least stable disease will enter short follow up phase till month 24 with radiology assessment every 6 months and visit every 12 weeks. After month 24 and for all patients with progressive disease, long-term follow-up assessments (including survival, disease status and next therapy information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30 Positive Peripheral T Cell Lymphoma (PTCL) Patients|
|Actual Study Start Date :||September 21, 2015|
|Actual Primary Completion Date :||September 24, 2019|
|Estimated Study Completion Date :||December 2021|
Experimental: Brentuximab Vedotin 16 cycles
Subjects will receive 1.8 mg/kg of brentuximab vedotin as an iv infusion administered on Day 1 of each 21-day cycle for a maximum of 16 cycles.
Drug: Brentuximab Vedotin
Brentuximab vedotin will be administered on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg and is administered by outpatient IV infusion given over approximately 30 minutes
Other Name: SGN35
- overall objective response rate (ORR) [ Time Frame: 1 year ]Overall objective response rate (ORR) is defined as the proportion of patients with complete remission (CR) or partial remission (PR) according to the Revised Response Criteria for Malignant Lymphoma
- Duration of response [ Time Frame: 1 year ]Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to lymphoma
- Complete remission rate (CR) [ Time Frame: 1 year ]The proportion of patients with complete remission (CR) according to the Revised Response Criteria for Malignant Lymphoma
- Progression-free survival (PSF) [ Time Frame: 1 year ]Progression-free survival (PFS) is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause
- Overall survival (OS) [ Time Frame: 1 year ]Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
- Adverse Events [ Time Frame: 1 year ]Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities
- Event-Free survival (EFS) [ Time Frame: 1 year ]Event-free survival (EFS) is defined as the time from start of study treatment to any treatment failure including disease progression, or discontinuation of treatment for any reason
- B symptom resolution rate [ Time Frame: 1 year ]B symptom resolution rate is defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period.
- CD30 expression [ Time Frame: 1 year ]Correlation between CD30 expression and response
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): NCT02497131
|Contact: Uffici Studi FILemail@example.com|
|Ematologia "L. & A. Seragnoli" - Policlinico S. Orsola Malpighi||Recruiting|
|Bologna, Italy, 40138|
|Contact: Vittorio Stefoni, MD +39.0516363680 firstname.lastname@example.org|
|A.O.Spedali civili di Brescia||Not yet recruiting|
|Principal Investigator: Giuseppe Rossi, MD|
|Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori||Recruiting|
|Principal Investigator: Paolo Corradini, MD|
|SC Ematologia - Città della Salute e della Scienza||Recruiting|
|Torino, Italy, 10126|
|Principal Investigator: Umberto Vitolo, MD|
|A.O. Universitaria S. Maria Della Misericordia Di Udine||Recruiting|
|Udine, Italy, 33100|
|Principal Investigator: Stefano Volpetti, MD|
|Principal Investigator:||Vittorio Stefoni, MD||Ematologia "L. & A. Seragnoli" - Policlinico S. Orsola Malpighi|