NCT04069845

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

March 17, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

August 25, 2019

Last Update Submit

March 13, 2021

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • the incidence of interstitial pneumonia

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

    up to one month after completion of study treatment

Secondary Outcomes (2)

  • overall response rate

    21 days after completion of study treatment

  • adverse events

    up to 30 days after completion of study treatment

Study Arms (1)

liposomal doxorubicin treatment

intravenous liposomal doxorubicin

Drug: liposomal doxorubicin

Interventions

liposomal doxorubicinDRUG

intravenous liposomal doxorubicin

liposomal doxorubicin treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

de novo lymphoma patients

You may qualify if:

  • histologically confirmed lymphoma
  • years
  • ECOG\<= 2
  • newly diagnosed lymphoma
  • liposomal doxorubicin is planned in the treatment
  • normal lung function
  • no history or malignancy
  • informed consented

You may not qualify if:

  • history of malignancy, now in the treatment
  • pregnant
  • serious infection
  • other uncontrollable conditions judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

WL Z

CONTACT

64370045zhao.weili@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 25, 2019

First Posted

August 28, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2021

Study Completion

August 30, 2021

Last Updated

March 17, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)