Chronic Lymphocytic LeukemiaNCT04094051
Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Ibrutinib
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Dec 2021
- How long will I take part?
- 10 Years
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Retrospective group: CLL/SLL patients who received CLL/SLL treatment before study initiation as judged by participating site physician. A telephone follow-up will be arranged at the time of study initiation to determine the disease progression, survival status, PRO assessments and ADR. If the patient is accessible, oral consent will be obtained and documented in the medical record before the retrospective data collection through chart review. If the patient is not accessible at the time of study initiation, ICF waiver approved by the IRB will be in place for the etrospective data collection according to the latest local regulation. Prospective group: CLL/SLL patients who are on ibrutinib treatment at the time of study initiation as judged by participating site physician or start ibrutinib treatment after study initiation. This group of patients can be divided into two subgroups.
Who may be able to join
- In the retrospective part:
- Male or female patients above 18 years old
- Patients underwent CLL treatment after Jan 1st, 2013
- Patient understand and voluntarily sign an ICF, if applicable.
- In the prospective part:
- Male or female patients above 18 years old
Show all 9Show fewer
- Patients diagnosed with CLL，including treatment- naïve patients or patients who have received ≤3 prior therapies
- Patients treated with ibrutinib as monotherapy or a part of combination therapy
- Patient understand and voluntarily sign an ICF.
Who cannot join
- In the retrospective part:
- Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
- Patients enrolled in interventional clinical trials of any drug for CLL treatment
- In the prospective part:
- Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
- Patients with contraindication listed in the package insert of ibrutinib
- Patients enrolled in interventional clinical trials of ibrutinib or any other drug for CLL treatment
- Patient received Ibrutinib treatment as maintenance therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Jianyong Li, PhD, lijianyonglm@126.com
About this study
Official title: A Retrospective and Prospective Observational Study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
This is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection.
- Being tested
- Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
In the retrospective period, clinical information of approximate 500 patients with CLL/SLL prior to the study initiation will be collected retrospectively through chart review. There will be one time follow-up to collect data on disease progression, survival status and patient-reported outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and disease characteristics
age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.
Measured: Up to 10 years
Treatment pattern
number of prior therapies, every treatment regimen, dose, cycle/treatment duration, stem cell therapy (SCT), progression-free survival (PFS), overall survival (OS), patient-reported outcome.
Measured: Baseline
Secondary outcomes (1)
Treatment response
PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Cross-sectional
- Enrolment
- 580 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094051
- Sponsor's protocol ID
- JNJ-54179060
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Observational Study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT04094051
- Acronym / sponsor ID
- JNJ-54179060
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Sep 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 is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Retrospective group: CLL/SLL patients who received CLL/SLL treatment before study initiation as judged by participating site physician. A telephone follow-up will be arranged at the time of study initiation to determine the disease progression, survival status, PRO assessments and ADR. If the patient is accessible, oral consent will be obtained and documented in the medical record before the retrospective data collection through chart review. If the patient is not accessible at the time of study initiation, ICF waiver approved by the IRB will be in place for the etrospective data collection according to the latest local regulation. Prospective group: CLL/SLL patients who are on ibrutinib treatment at the time of study initiation as judged by participating site physician or start ibrutinib treatment after study initiation. This group of patients can be divided into two subgroups.
Key inclusion criteria (9 listed)
- In the retrospective part:
- In the prospective part:
Key exclusion criteria (8 listed)
- In the retrospective part:
- In the prospective part:
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 |
|---|---|---|
| IbrutinibIn the retrospective period, clinical information of approximate 500 patients with CLL/SLL prior to the study initiation will be collected retrospectively through chart review. There will be one time follow-up to collect data on disease progression, survival status and patient-reported outcomes. | Drug | – |
Primary outcome
Patient and disease characteristics
Time frame: Up to 10 years
age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.
Treatment pattern
Time frame: Baseline
number of prior therapies, every treatment regimen, dose, cycle/treatment duration, stem cell therapy (SCT), progression-free survival (PFS), overall survival (OS), patient-reported outcome.
1 secondary outcome
Treatment response
Time frame: Up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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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 Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 9 inclusion and 8 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 18 Sep 2019. 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 Jianyong Li, Ph.D. (025-83718836, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and disease characteristics (time frame: Up to 10 years). The study lists 2 primary outcomes in all. 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 18 Sep 2019.