Clinical trial NCT04872621: Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation
Official title: Calquence 100 mg Capsules General Drug Use-Results Study; All Patient Investigation in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed or refractory chronic lymphocytic leukaemia (small lymphocytic lymphoma) who are treated with the product

Brief summary: To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting

Detailed description: To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting.

This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.

Eligibility criteria: Inclusion Criteria:

Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product -

Exclusion Criteria:

None

-

Primary outcomes:
measure: Incidence of ADRs
timeFrame: 52weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References: