A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin

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: Lymphoma
• Intervention / Treatment: Drug: liposomal doxorubicin

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: WL Z; Phone Number: 610707 64370045; Email: zhao.weili@yahoo.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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	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	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

• Sponsor: Ruijin Hospital

Study record dates

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: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• 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