Chronic Lymphocytic LeukemiaNCT05899543
Determining Clinical Study Experiences of Chronic Lymphocytic Leukemia Patients
An observational study of Chronic Lymphocytic Leukemia, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
This research study aims to address the limited understanding of the challenges faced by specific demographic groups of chronic lymphocytic leukemia patients in their participation in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Jul 2026
- 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: Chronic lymphocytic leukemia patients who are actively participating in a clinical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient has been diagnosed with chronic lymphocytic leukemia
- Patient is a minimum of 18 years or older
- Able to comprehend the investigational nature of the protocol and provide informed consent
Who cannot join
- Pregnant or lactating women
- Patients who are currently receiving any other investigational drug
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
About this study
Official title: Exploring Patient Experiences of Individuals Joining Chronic Lymphocytic Leukemia Clinical Trials
This research study aims to address the limited understanding of the challenges faced by specific demographic groups of chronic lymphocytic leukemia patients in their participation in clinical trials.
This trial will scrutinize the experiences of patients diagnosed with chronic lymphocytic leukemia as they take part in a separate medical intervention clinical trial. The focus will be on tracking the rates of completion and withdrawal among these individuals.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chronic lymphocytic leukemia patients.
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of chronic lymphocytic leukemia patients who decide to join in a clinical study
Measured: 3 months
Rate of patients who remain in an chronic lymphocytic leukemia clinical study to completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899543
- Sponsor's protocol ID
- 83115421
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nabhan C, Rosen ST. Chronic lymphocytic leukemia: a clinical review. JAMA. 2014 Dec 3;312(21):2265-76. doi: 10.1001/jama.2014.14553.
PubMed 25461996Iskierka-Jazdzewska E, Robak T. Investigational treatments for chronic lymphocytic leukemia: a focus on phase 1 and 2 clinical trials. Expert Opin Investig Drugs. 2020 Jul;29(7):709-722. doi: 10.1080/13543784.2020.1770225. Epub 2020 May 27.
PubMed 32407139Molica S. The clinical safety of ibrutinib in chronic lymphocytic leukemia. Expert Opin Drug Saf. 2015 Oct;14(10):1621-9. doi: 10.1517/14740338.2015.1084286. Epub 2015 Sep 11.
PubMed 26359217
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Patient Experiences of Individuals Joining Chronic Lymphocytic Leukemia Clinical Trials
- ClinicalTrials.gov ID
- NCT05899543
- Acronym / sponsor ID
- 83115421
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Jun 2023 (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 research study aims to address the limited understanding of the challenges faced by specific demographic groups of chronic lymphocytic leukemia patients in their participation in clinical trials.
This trial will scrutinize the experiences of patients diagnosed with chronic lymphocytic leukemia as they take part in a separate medical intervention clinical trial. The focus will be on tracking the rates of completion and withdrawal among these individuals.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chronic lymphocytic leukemia patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic lymphocytic leukemia patients who are actively participating in a clinical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with chronic lymphocytic leukemia
- Patient is a minimum of 18 years or older
- Able to comprehend the investigational nature of the protocol and provide informed consent
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Patients who are currently receiving any other investigational drug
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of chronic lymphocytic leukemia patients who decide to join in a clinical study
Time frame: 3 months
Rate of patients who remain in an chronic lymphocytic leukemia clinical study to completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 25461996Nabhan C, Rosen ST. Chronic lymphocytic leukemia: a clinical review. JAMA. 2014 Dec 3;312(21):2265-76. doi: 10.1001/jama.2014.14553.
- Background: PubMed 32407139Iskierka-Jazdzewska E, Robak T. Investigational treatments for chronic lymphocytic leukemia: a focus on phase 1 and 2 clinical trials. Expert Opin Investig Drugs. 2020 Jul;29(7):709-722. doi: 10.1080/13543784.2020.1770225. Epub 2020 May 27.
- Background: PubMed 26359217Molica S. The clinical safety of ibrutinib in chronic lymphocytic leukemia. Expert Opin Drug Saf. 2015 Oct;14(10):1621-9. doi: 10.1517/14740338.2015.1084286. Epub 2015 Sep 11.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
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, run by Power Life Sciences Inc. at 1 site in United States.
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 3 inclusion and 3 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 12 Jun 2023. 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 United States. 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 Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of chronic lymphocytic leukemia patients who decide to join in a clinical study (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05899543, which also lists 3 linked publications.
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 12 Jun 2023.