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A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin

Conditions
Lymphoma
Interventions
Registration Number
NCT04069845
Lead Sponsor
Ruijin Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
2000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
liposomal doxorubicin treatmentliposomal doxorubicinintravenous liposomal doxorubicin
Primary Outcome Measures
NameTimeMethod
the incidence of interstitial pneumoniaup 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
NameTimeMethod
adverse eventsup 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

overall response rate21 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

Trial Locations

Locations (1)

Ruijin Hospital

🇨🇳

Shanghai, Shanghai, China

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