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
- 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
- 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
Group Intervention Description liposomal doxorubicin treatment liposomal doxorubicin intravenous liposomal doxorubicin
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China