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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03161054
Other study ID # FIL_DEVEC
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 12, 2017
Est. completion date June 21, 2021

Study information

Verified date December 2021
Source Fondazione Italiana Linfomi ONLUS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years) with aggressive B-Cell lymphomas


Description:

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Study Design


Intervention

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Sponsors (1)

Lead Sponsor Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Remission Rate (CRR) The primary efficacy endpoint is defined in terms of complete response (CR), including complete response unconfirmed (CRu), according to Recommendations of an International Workshop to Standardise Response Criteria for Non-Hodgkin´s Lymphomas. 30 months
Primary Incidence of adverse events The primary safety endpoint is defined as incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 30 months
Secondary Overall response rate (ORR) ORR, defined as the proportion of patients who achieved a CR (including CRu) or a PR. 30 months
Secondary Clinical Benefit Defined as the percentage of patients who achieved a CR (including CRu), a PR and a SD. 30 months
Secondary Progression Free Survival (PFS) defined as the time from registration to the first occurrence of progression or relapse or death for any cause other causes than lymphoma, or the date of last follow-up in censored patients. 36
Secondary Event Free Survival (EFS) EFS, defined as the time from registration until: early withdrawal, less than CRu, relapse or progression or death by other causes than lymphoma in patients who achieved CR or CRu after the EOI phase. 36
Secondary Disease Free Survival (DFS) DFS: calculated for patients in CR/CRu after induction phase, from the date of response/end treatment until relapse, death by other causes than lymphoma or last follow-up in censored patients. 36
Secondary Overall Survival (OS) OS, calculated from the date of registration until death for any cause or last follow-up in censored patients. 36
Secondary Patient-Reported Outcome (PRO) PRO per European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life (QLQ-30) questionnaire 36
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