A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin

March 13, 2021 updated by: Zhao Weili, Ruijin Hospital

A Registry Study on the Risk Factors of Interstitial Pneumonia in Lymphoma Patients Treated With Liposomal Doxorubicin

This study is to evaluate the incidence of interstitial pneumonia in lymphoma patients treated with liposomal doxorubucin. The treatment response and other adverse events will also be studied.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:
          • Pp X, MD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

de novo lymphoma patients

Description

Inclusion Criteria:

  • histologically confirmed lymphoma
  • 18-80 years
  • ECOG<= 2
  • newly diagnosed lymphoma
  • liposomal doxorubicin is planned in the treatment
  • normal lung function
  • no history or malignancy
  • informed consented

Exclusion Criteria:

  • history of malignancy, now in the treatment
  • pregnant
  • serious infection
  • other uncontrollable conditions judged by the investigator

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
liposomal doxorubicin treatment
intravenous liposomal doxorubicin
Drug: liposomal doxorubicin
intravenous liposomal doxorubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of interstitial pneumonia
Time Frame: up to one month after completion of study treatment
interstitial pneumonia is defined as positive CT scan with or without positive respiratory symptoms
up to one month after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: 21 days after completion of study treatment
percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
21 days after completion of study treatment
adverse events
Time Frame: up to 30 days after completion of study treatment
number of participants with treatment-related adverse events mainly include liposomal related AEs, eg cardiotoxicity and the incidence of hand-foot syndrome
up to 30 days after completion of study treatment

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

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)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

August 25, 2019

First Submitted That Met QC Criteria

August 25, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Realipo-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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