NCT06235047

Brief Summary

Study on the use of a polychemotherapy scheme based on liposomal doxorubicin, vinblastine and dacarbazine (MVD) as first line in the therapy of elderly patients affected by classic Hodgkin lymphoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

January 23, 2024

Last Update Submit

January 23, 2024

Conditions

Classic Hodgkin Lymphoma

Keywords

cHL>60yliposomal doxorubicin

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The primary endpoint was the activity of the liposomal doxorubicin-based front-line strategy in terms of OS.

    from 1 January 2013 to 1 January 2023

Secondary Outcomes (3)

  • Progression-free survival

    from 1 January 2013 to 1 January 2023

  • End of Treatment response rate

    from 1 January 2013 to 1 January 2023

  • Adverse events

    from 1 January 2013 to 1 January 2023

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

over60 year old c-HL patients, previously untreated with Ann Arbor stage III or IV. ECOG PS 0-3, GLS ≥-20% at echocardiographic assessment and human immunodeficiency virus negativity.

You may qualify if:

  • previously untreated, biopsy-proven c-HL
  • Ann Arbor stage III or IV
  • ECOG PS 0-3
  • LVEF≥50% at echocardiographic assessment
  • human immunodeficiency virus negativity.
  • any GLS value

You may not qualify if:

  • Ann Arbor stage I or II,
  • concomitant major illnesses
  • creatinine clearance \<30 ml/min
  • serum transaminases more than three times the normal value
  • total bilirubin \>3.4 mg/dl
  • absolute neutrophil count \<500/mm 3
  • hemoglobin level \<9 g/dL
  • platelet count \<75 000/mm 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, 80131, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2024

First Posted

January 31, 2024

Study Start

January 1, 2013

Primary Completion

January 1, 2023

Study Completion

January 8, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

IT(1)