Clinical trial NCT03816683: A Disease Registry of Patients With Mantle Cell Lymphoma
Official title: Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients With Mantle Cell Lymphoma Treated With Novel Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma
Registry
MCL novel therapy
MCL treatment patterns
MCL reported outcomes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-01-25
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of MCL who have received any line of novel MCL treatment within the past 6 months (and treatment is ongoing at the time of enrollment).

Brief summary: The purpose of this study is to create a patient registry in order to assess treatment patterns, physician reported clinical outcomes and patient-reported health-related quality of life among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

Detailed description: Newer targeted therapies (monotherapy or in combination with other agents) have been recently approved in the United States for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy. The approval of these newer therapies will have an impact on the treatment patterns, toxicity patterns, and outcomes in the MCL population. A prospective, observational study will help to better understand the evolving real-world treatment outcomes (including treatment patterns, reasons for discontinuation/dose reduction, treatment interruption or treatment switches), physician-reported clinical outcomes, and patient-reported symptoms and health-related quality of life (HRQoL) among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with Mantle Cell Lymphoma (MCL)
* Informed consent for participation
* Age ≥ 18 years old, as of the first observed diagnosis of MCL
* Patients for whom a clinical decision has been made to initiate novel therapy in the last 6 months, limited to the following novel agent categories:

  * Bcl-2 inhibitors
  * BTK inhibitors
  * Immunomodulatory agents
  * Phosphoinositide 3-kinase inhibitors The novel agent must have been granted approval in at least one haematological cancer. Treatment must be ongoing at the time of enrollment.

Exclusion Criteria:

• Patient is participating in a clinical study that prohibits participation in non-interventional studies, or where treatment is blinded, at the time of consent.

Primary outcomes:
measure: The frequency and proportion of patients exposed to each novel agent therapy
timeFrame: 24 to 60 months
measure: The frequency and proportion of patients exposed to novel agent by therapy regimen
timeFrame: 24 to 60 months
measure: The frequency and proportion of patients exposed to novel agent by line of therapy
timeFrame: 24 to 60 months
measure: The frequency and proportion of patients exposed to novel agent by therapy class
timeFrame: 24 to 60 months.
measure: The rate of patients who change novel agent therapy dose (in months)
timeFrame: 24 to 60 months.
measure: The rate of patients who interrupt novel agent therapy (in months)
timeFrame: 24 to 60 months
measure: The rate of patients who discontinue novel agent therapy (in months)
timeFrame: 24 to 60 months
measure: The duration of MCL treatment
timeFrame: 24 to 60 months
measure: Estimate the overall response rate (ORR) among patients diagnosed with MCL and initiating treatment with novel therapies
timeFrame: 24 to 60 months.
measure: Estimate the complete response rate (CR) among patients diagnosed with MCL and initiating treatment with novel therapies.
timeFrame: 24 to 60 months.
measure: Estimate progression-free survival (PFS) among patients diagnosed with MCL and initiating treatment with novel therapies.
timeFrame: 24 to 60 months
measure: Estimate event-free survival (EFS) among patients diagnosed with MCL and initiating treatment with novel therapies.
timeFrame: 24 to 60 months
measure: Estimate overall survival (OS) among patients diagnosed with MCL and initiating treatment with novel therapies.
timeFrame: 24 to 60 months
Secondary outcomes:
measure: The frequency of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.
timeFrame: 24 to 60 months
measure: The proportion of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.
timeFrame: 24 to 60 months
measure: Estimate the frequency of serious adverse events (SAEs) in patients with MCL
timeFrame: 24 to 60 months
measure: Estimate the frequency of reported serious adverse safety events and adverse events leading to treatment changes associated with novel agents in patients with MCL
timeFrame: 24 to 60 months
measure: Estimate the frequency and proportion of patients experiencing a clinical event of interest (related to MCL or MCL treatment)
timeFrame: 24 to 60 months
measure: Estimate the frequency and proportion of patients experiencing healthcare resource utilization (HCRU), such as inpatient or emergency department visits
timeFrame: 24 to 60 months
measure: Tabulate HRQoL responses for the validated EORTC QLC-C30 Patient Reported Outcome (PRO) in patients with MCL
timeFrame: 24 to 60 months
measure: Tabulate HRQoL responses for the three selected, validated PRO-CTCAE PRO measures in patients with MCL
timeFrame: 24 to 60 months
measure: Tabulate HRQoL responses for the validated PRO EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in patients with MCL
timeFrame: 24 to 60 months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Research Site
state: Alabama
city: Clovis
country: United States
facility: Research Site
state: California
city: Boulder
country: United States
facility: Research Site
state: Colorado
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Duluth
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: Research Site
state: Minnesota
city: Saint Paul
country: United States
facility: Research Site
state: Minnesota
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Berkeley Heights
country: United States
facility: Research Site
state: New Jersey
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: East Syracuse
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Danville
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Senior Medical Director, Haematology
name: Richard Hermann
role: STUDY_DIRECTOR
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