Mantle Cell LymphomaNCT06049472
Patient Perspectives in Mantle Cell Lymphoma Clinical Research
An observational study of Mantle Cell Lymphoma, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Clinical studies with a distinct emphasis on mantle cell lymphoma play a pivotal role in evaluating the safety and effectiveness of novel treatments for this disease. These trials are instrumental in ascertaining whether new medications surpass conventional therapies, providing substantial evidence to endorse their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Oct 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: Mantle cell lymphoma patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Who may be able to join
- Confirmed diagnosis of mantle cell lymphoma
- No serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Concurrent participation in another therapeutic clinical trial.
- Subject has an uncontrolled infection
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Exploring Patient Engagement Patterns and Participation Trends in Mantle Cell Lymphoma Clinical Trials
Clinical studies with a distinct emphasis on mantle cell lymphoma play a pivotal role in evaluating the safety and effectiveness of novel treatments for this disease. These trials are instrumental in ascertaining whether new medications surpass conventional therapies, providing substantial evidence to endorse their broad utilization.
This particular study stands out as it centers on the firsthand experiences of individuals battling mantle cell lymphoma who are actively engaged in a clinical trial featuring medicinal interventions. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this patient group.
- Conditions
- Mantle Cell Lymphoma
- Keywords
- mantle cell lymphoma
- Medical subject headings
- Lymphoma, Mantle-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in a mantle cell lymphoma clinical study
Measured: 3 months
Rate of patients who remain in a mantle cell lymphoma clinical study to trial 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 posted22 Sep 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 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 Mantle Cell LymphomaStudies 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
- NCT06049472
- Sponsor's protocol ID
- 70247036
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. doi: 10.1002/cncr.22093.
PubMed 16878325Campbell J, Hurtado S, Kutz C, Soto K, Ernst D. [Cytarabine and hematopoietic cell transplantation for mantle cell lymphoma. Analysis of 20 patients]. Rev Med Chil. 2019;147(1):9-17. doi: 10.4067/S0034-98872019000100009. Spanish.
PubMed 30848759Dasappa L, Suresh Babu MC, Sirsath NT, Suresh TM, Govind Babu K, Sathyanarayna V, Lokesh KN, Lakshmaiah KC. Primary gastrointestinal mantle cell lymphoma: a retrospective study. J Gastrointest Cancer. 2014 Dec;45(4):481-6. doi: 10.1007/s12029-014-9655-2.
PubMed 25316096
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Patient Engagement Patterns and Participation Trends in Mantle Cell Lymphoma Clinical Trials
- ClinicalTrials.gov ID
- NCT06049472
- Acronym / sponsor ID
- 70247036
- Conditions
- Mantle Cell Lymphoma
- Keywords
- mantle cell lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 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.
Clinical studies with a distinct emphasis on mantle cell lymphoma play a pivotal role in evaluating the safety and effectiveness of novel treatments for this disease. These trials are instrumental in ascertaining whether new medications surpass conventional therapies, providing substantial evidence to endorse their broad utilization.
This particular study stands out as it centers on the firsthand experiences of individuals battling mantle cell lymphoma who are actively engaged in a clinical trial featuring medicinal interventions. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this patient group.
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
- Mantle cell lymphoma patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of mantle cell lymphoma
- No serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Concurrent participation in another therapeutic clinical trial.
- Subject has an uncontrolled infection
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of 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 patients who decide to enroll in a mantle cell lymphoma clinical study
Time frame: 3 months
Rate of patients who remain in a mantle cell lymphoma clinical study to trial 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 22 Sep 2023.
- Background: PubMed 16878325Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. doi: 10.1002/cncr.22093.
- Background: PubMed 30848759Campbell J, Hurtado S, Kutz C, Soto K, Ernst D. [Cytarabine and hematopoietic cell transplantation for mantle cell lymphoma. Analysis of 20 patients]. Rev Med Chil. 2019;147(1):9-17. doi: 10.4067/S0034-98872019000100009. Spanish.
- Background: PubMed 25316096Dasappa L, Suresh Babu MC, Sirsath NT, Suresh TM, Govind Babu K, Sathyanarayna V, Lokesh KN, Lakshmaiah KC. Primary gastrointestinal mantle cell lymphoma: a retrospective study. J Gastrointest Cancer. 2014 Dec;45(4):481-6. doi: 10.1007/s12029-014-9655-2.
- 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 Mantle Cell Lymphoma, 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 22 Sep 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 patients who decide to enroll in a mantle cell lymphoma 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 NCT06049472, 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 22 Sep 2023.