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A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04069845
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 11, 2020
Information provided by (Responsible Party):
Zhao Weili, 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.

Condition or disease Intervention/treatment
Lymphoma Drug: liposomal doxorubicin

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 690 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Registry Study on the Risk Factors of Interstitial Pneumonia in Lymphoma Patients Treated With Liposomal Doxorubicin
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Pneumonia

Group/Cohort Intervention/treatment
liposomal doxorubicin treatment Drug: liposomal doxorubicin
intravenous liposomal doxorubicin

Primary Outcome Measures :
  1. the incidence of interstitial pneumonia [ Time Frame: 2 years ]
    based on CT scan, patient symptoms and PFT

Secondary Outcome Measures :
  1. overall response rate [ Time Frame: 2 years ]
  2. adverse events [ Time Frame: 2 years ]
    mainly include liposomal related AEs, eg cardiatoxicity and the incidence of hand-foot syndrome

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
de novo lymphoma patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04069845

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Contact: WL Z 64370045 ext 610707

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China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Pp X, MD         
Sponsors and Collaborators
Ruijin Hospital
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Responsible Party: Zhao Weili, professor, Ruijin Hospital Identifier: NCT04069845    
Other Study ID Numbers: Realipo-01
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action