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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04069845
Enrollment
2000
Registered
2019-08-28
Start date
2019-08-01
Completion date
2021-08-30
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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.

Interventions

DRUGliposomal doxorubicin

intravenous liposomal doxorubicin

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of interstitial pneumoniaup to one month after completion of study treatmentinterstitial pneumonia is defined as positive CT scan with or without positive respiratory symptoms

Secondary

MeasureTime frameDescription
overall response rate21 days after completion of study treatmentpercentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
adverse eventsup to 30 days after completion of study treatmentnumber of participants with treatment-related adverse events mainly include liposomal related AEs, eg cardiotoxicity and the incidence of hand-foot syndrome

Countries

China

Contacts

Primary ContactWL Z
zhao.weili@yahoo.com64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026