A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04069845
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 80.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: liposomal doxorubicin

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Registry Study on the Risk Factors of Interstitial Pneumonia in Lymphoma Patients Treated With Liposomal Doxorubicin
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
liposomal doxorubicin treatment intravenous liposomal doxorubicin	Drug: liposomal doxorubicin; intravenous liposomal doxorubicin

Outcome Measures

Primary Outcome Measures

1. the incidence of interstitial pneumonia [up to one month after completion of study treatment]

   interstitial pneumonia is defined as positive CT scan with or without positive respiratory symptoms

Secondary Outcome Measures

1. overall response rate [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

2. adverse events [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Weili, professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT04069845
• Other Study ID Numbers: Realipo-01
• First Posted: Aug 28, 2019
• Last Update Posted: Mar 17, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Doxorubicin; Liposomal doxorubicin

Study Results

No Results Posted as of Mar 17, 2021