Leukemia, Lymphocytic, Chronic, B-CellNCT03476655
Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Mantle-Cell, run by Johnson & Johnson Private Limited at 8 sites in India.
Trial summary
The purpose of this study is to describe the effectiveness (overall response rate [ORR] and time to progression [TPP]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
- What is being tested?
- Ibrutinib
- How many people
- 40 participants
- Where
- 8 sitesIndia
- Study dates
- 28 Apr 2018to 31 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants treated with ibrutinib per routine clinical care before 30 April 2018 in India and who have progressed on at least one prior line of therapy or CLL participants with deletion 17p (deletions in the short arm of chromosome 17).
Who may be able to join
- Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
- CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians
Who cannot join
- Any contraindications to ibrutinib use according to the current version of the Prescribing information in India
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Apollo Hospitals International Limited
Ahmedabad, 382428
Healthcare Global (HCG) Hospital
Bangalore, 560013
Fortis Memorial Research Institute
Gūrgaon, 122002
Basavatarakam Indo-American Hospital
Hyderabad, 500034
Bhagwan Mahaveer Hospital & Research Centre
Jaipur, 302017
Tata Medical Center
Kolkata, 700156
All India Institute of Medical Sciences
New Delhi, 110029
Yashoda Hematology Clinic
Pune, 411002
About this study
Official title: Clinical Outcomes of CLL and MCL Patients Treated With Ibrutinib: An Observational Retrospective Medical Chart Review From India
The purpose of this study is to describe the effectiveness (overall response rate [ORR] and time to progression [TPP]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
- Being tested
- Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called IMBRUVICA
No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Chronic Lymphocytic Leukemia (CLL) | This study will collect retrospective data on effectiveness and outcome parameters for participants of CLL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant. Receives: Drug: Ibrutinib | |
| Participants with Mantle Cell Lymphoma (MCL) | This study will collect retrospective data on effectiveness and outcome parameters for participants of MCL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR is defined as achievement of complete response (CR) or partial response (PR) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 guidelines for Chronic Lymphocytic Leukemia (CLL) and Mantle-cell Lymphoma (MCL). CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.
Measured: Up to 14 months
Time to Progression (TTP)
Time to progression will be reported for the observed participants receiving ibrutinib. TTP is defined as the period from study entry until objective disease progression (time from the date of randomization until disease progression or death due to progression, whichever occur first).
Measured: Up to 14 months
Percentage of Participants with Complete Response (CR)
Percentage of participants with CR will be reported. CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow.
Measured: Up to 14 months
Percentage of Participants with Partial Response (PR)
Percentage of participants with PR will be reported. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.
Measured: Up to 14 months
Percentage of Participants with Stable Disease (SD)
Percentage of participants with SD will be reported. Participants who have not achieved a CR or a PR, and who have not exhibited progressive disease will be considered to have stable disease.
Measured: Up to 14 months
Percentage of Participants with Progressive Disease (PD)
Percentage of participants with PD will be reported. PD is defined as 50% or more increase in lymph nodes or the appearance of new enlarged lymph nodes; 50% or more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
Measured: Up to 14 months
Secondary outcomes (5)
Median time to Response with Ibrutinib
Median time to response with ibrutinib in CLL and MCL participants will be reported. Time to response is defined as the time from start of ibrutinib therapy until objective response (CR or PR assessed by the investigator, based on physical examinations, CT scans, laboratory results, and bone marrow examinations, according to the modified 2008 IWCLL response criteria).
Measured: Up to 14 months
Change from Baseline in Hemoglobin Levels
Change from baseline in blood hemoglobin level will be reported.
Measured: Baseline up to 14 months
Change from Baseline in Platelet Counts
Change from baseline in blood platelet counts will be reported.
Measured: Baseline up to 14 months
Number of Participants with Response to Ibrutinib by Prior Lines of Therapy
Number of participants, who progresses on at least one prior line of therapy, with response to ibrutinib will be reported.
Measured: Up to 14 months
Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)
Number of participants with hematological and non-hematological ADR will be reported. An adverse drug reaction (ADR) is defined as a response to a medicinal (investigational or non-investigational) product that is noxious and unintended. The phrase "response to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start28 Apr 2018
- Primary completion14 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Private Limited Clinical Trial, Study director, Johnson & Johnson Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476655
- Sponsor's protocol ID
- CR108441
- Other IDs
- 54179060LYM4007
- Status last verified
- Jan 2025
- First submitted
- 19 Mar 2018
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of CLL and MCL Patients Treated With Ibrutinib: An Observational Retrospective Medical Chart Review From India
- ClinicalTrials.gov ID
- NCT03476655
- Acronym / sponsor ID
- CR108441
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Mar 2018 (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.
The purpose of this study is to describe the effectiveness (overall response rate [ORR] and time to progression [TPP]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Chronic Lymphocytic Leukemia (CLL) | – | Drug: IbrutinibThis study will collect retrospective data on effectiveness and outcome parameters for participants of CLL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant. |
| Participants with Mantle Cell Lymphoma (MCL) | – | Drug: IbrutinibThis study will collect retrospective data on effectiveness and outcome parameters for participants of MCL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants treated with ibrutinib per routine clinical care before 30 April 2018 in India and who have progressed on at least one prior line of therapy or CLL participants with deletion 17p (deletions in the short arm of chromosome 17).
Key inclusion criteria (2 listed)
- Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
- CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians
Key exclusion criteria (1 listed)
- Any contraindications to ibrutinib use according to the current version of the Prescribing information in India
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 |
|---|---|---|
| IbrutinibAlso: IMBRUVICANo study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed. | Drug | Participants with Chronic Lymphocytic Leukemia (CLL), Participants with Mantle Cell Lymphoma (MCL) |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 14 months
ORR is defined as achievement of complete response (CR) or partial response (PR) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 guidelines for Chronic Lymphocytic Leukemia (CLL) and Mantle-cell Lymphoma (MCL). CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.
Time to Progression (TTP)
Time frame: Up to 14 months
Time to progression will be reported for the observed participants receiving ibrutinib. TTP is defined as the period from study entry until objective disease progression (time from the date of randomization until disease progression or death due to progression, whichever occur first).
Percentage of Participants with Complete Response (CR)
Time frame: Up to 14 months
Percentage of participants with CR will be reported. CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow.
Percentage of Participants with Partial Response (PR)
Time frame: Up to 14 months
Percentage of participants with PR will be reported. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.
Percentage of Participants with Stable Disease (SD)
Time frame: Up to 14 months
Percentage of participants with SD will be reported. Participants who have not achieved a CR or a PR, and who have not exhibited progressive disease will be considered to have stable disease.
Percentage of Participants with Progressive Disease (PD)
Time frame: Up to 14 months
Percentage of participants with PD will be reported. PD is defined as 50% or more increase in lymph nodes or the appearance of new enlarged lymph nodes; 50% or more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
5 secondary outcomes
Median time to Response with Ibrutinib
Time frame: Up to 14 months
Change from Baseline in Hemoglobin Levels
Time frame: Baseline up to 14 months
Change from Baseline in Platelet Counts
Time frame: Baseline up to 14 months
Number of Participants with Response to Ibrutinib by Prior Lines of Therapy
Time frame: Up to 14 months
Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)
Time frame: Up to 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
Johnson & Johnson Private Limited Clinical Trial study director
Johnson & Johnson Private Limited
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Mantle-Cell, run by Johnson & Johnson Private Limited at 8 sites in India.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 14 months). The study lists 6 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 3 Feb 2025.