Observational in Hodgkin Lymphoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Hodgkin Lymphoma

Intervention / Treatment

Other: observational

Detailed Description

This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.

The regimen consisted of 3-day outpatient intravenous infusions of 1.8 mg/kg Bv on Day 1 of each 3-week cycle (as established by Younes and colleagues) sequentially combined with bendamustine (at least 24 hours after Bv, precisely on days 2 and 3 of the treatment cycle; as reported by Picardi et al) at a fixed dose of 120 mg/m2 per day.

All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell (PBSC) collection (performed with granulocyte colony-stimulating factor [G-CSF] and endoxan or plerixafor, if necessary) and proceeded to ASCT at any time beyond cycle 4.

The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment.

Prior to the first cycle of Bv-Bs, all patients underwent a clinical evaluation that included assessment of B symptoms, World Health Organization performance status, and measurement of palpable lesions. In particular, imaging procedures were conducted after the second and fourth cycles or prior to ASCT. The response was based on international criteria (Cheson et al, 2016). PET scans were considered positive or negative based on the Deauville 5-point scale criteria.

Study Type

Observational

Enrollment (Actual)

32

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.

Description

Inclusion Criteria:

patients age between 18 years and 60 years;
histological confirmation of CD30+ subtype cHL at first relapse or at refractory (patients who have failed to achieve complete remission at the end of treatment with 4-6 cycles of ABVD or who have progressed early during front-line treatment [after 2 cycles of ABVD] with interim FDG-PET/CT with Deauville scale score of 5 [primary refractory patients])
treatment with at least 1 cycle of Bs and Bv at doses of 120 mg/m2 and 1.8 mg/kg, respectively
metabolically active disease measurable at fluoro-desossi-glucose-positron emission tomography/computed tomography (FDG-PET/CT)
EGOG performance status 0-2 (or 3, if due to illness).

Exclusion Criteria:

patients not fulfilling inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: 10 year period	survival	10 year period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression overall survival Time Frame: 10 year period	survival	10 year period
Response to treatment Time Frame: at end of 4 cycles treatment (each cycle of 28 days)	Complete Metabolic Remission rate	at end of 4 cycles treatment (each cycle of 28 days)
Incidence of treatment emergent adverse events Time Frame: during 4 cycles of treatment (each cycle of 28 days)	side effect to regimen related to both Brentuximab and bendamustine	during 4 cycles of treatment (each cycle of 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)