LymphomaNCT04069845
A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin
An observational study of Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- liposomal doxorubicin
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Aug 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: de novo lymphoma patients
Who may be able to join
- 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
Who cannot join
- history of malignancy, now in the treatment
- pregnant
- serious infection
- other uncontrollable conditions judged by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Pp X, MD
About this study
Official title: A Registry Study on the Risk Factors of Interstitial Pneumonia in Lymphoma Patients Treated With Liposomal Doxorubicin
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.
- Conditions
- Lymphoma
- Being tested
- liposomal doxorubicin
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal doxorubicinDrug
intravenous liposomal doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| liposomal doxorubicin treatment | intravenous liposomal doxorubicin Receives: Drug: liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of interstitial pneumonia
interstitial pneumonia is defined as positive CT scan with or without positive respiratory symptoms
Measured: up to one month after completion of study treatment
Secondary outcomes (2)
overall response rate
percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: 21 days after completion of study treatment
adverse events
number of participants with treatment-related adverse events mainly include liposomal related AEs, eg cardiotoxicity and the incidence of hand-foot syndrome
Measured: up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069845
- Sponsor's protocol ID
- Realipo-01
- Status last verified
- Jan 2021
- First submitted
- 25 Aug 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study on the Risk Factors of Interstitial Pneumonia in Lymphoma Patients Treated With Liposomal Doxorubicin
- ClinicalTrials.gov ID
- NCT04069845
- Acronym / sponsor ID
- Realipo-01
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liposomal doxorubicin treatment | – | Drug: liposomal doxorubicinintravenous liposomal doxorubicin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- de novo lymphoma patients
Key inclusion criteria (8 listed)
- histologically confirmed lymphoma
- 18-80 years
- ECOG<= 2
- newly diagnosed lymphoma
- liposomal doxorubicin is planned in the treatment
Key exclusion criteria (4 listed)
- history of malignancy, now in the treatment
- pregnant
- serious infection
- other uncontrollable conditions judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal doxorubicinintravenous liposomal doxorubicin | Drug | liposomal doxorubicin treatment |
Primary outcome
the incidence of interstitial pneumonia
Time frame: up to one month after completion of study treatment
interstitial pneumonia is defined as positive CT scan with or without positive respiratory symptoms
2 secondary outcomes
overall response rate
Time frame: 21 days after completion of study treatment
adverse events
Time frame: up to 30 days after completion of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WL Z (64370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of interstitial pneumonia (time frame: up to one month after completion of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.