Clinical trial NCT06049472: Patient Perspectives in Mantle Cell Lymphoma Clinical Research
Official title: Exploring Patient Engagement Patterns and Participation Trends in Mantle Cell Lymphoma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mantle Cell Lymphoma
Keywords: mantle cell lymphoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients who decide to enroll in a mantle cell lymphoma clinical study
timeFrame: 3 months
measure: Rate of patients who remain in a mantle cell lymphoma clinical study to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Campbell 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.
citation: Dasappa 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.