Tam Moleküler Yanıt Elde Eden Kronik Miyeloid Lösemi Hastalarında Tirozin Kinaz İnhibitörlerinin Kesilmesinin Bütçe Etkisinin Olasılıklı Markov Yaklaşımıyla Analizi

Sade dilde özet

Bu çalışma, kronik miyeloid lösemi (chronic myeloid leukemia) hastalarında tam moleküler yanıt elde edildikten sonra tirozin kinaz inhibitörü (TKİ) tedavisinin kesilmesinin sağlık sistemi üzerindeki bütçe etkisini olasılıklı bir modelle analiz etmiştir. Çalışma, 18 yaş ve üzeri, en az 3 yıl düzenli TKİ tedavisi almış ve tedavisini bırakmış hastaların kayıtlarına dayanmaktadır. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

University Hospital, Bordeaux

Müdahale

Budget impact

Başlangıç

07.12.2016

Tahmini bitiş

01.04.2019

Ülkeler

France

İlgili genler

Merkezler

• Bordeaux, France

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Study period between 01/01/2005 and 12/31/2015 (cf. figure) including:

* Inclusion period: 01/01/2008 to 12/31/2014;
* Date of inclusion: date of the last TKI reimbursement before discontinuation which will be defined by the absence of any TKI reimbursement without the occurrence of death during at least 61 days following the 30-day coverage period of a TKI reimbursement;
* History: 3-year period;
* Follow-up: at least 1 year after inclusion or until death whatever occurs first.

Inclusion criteria for CML population

* Patients aged 18 years or over;
* Patients with LTD registration or hospitalization for CML (primary, associated and linked ICD-10 diagnosis code, i.e. C92.1 or C921) during the study period;
* Patients who discontinued their TKI treatment for the first time during the inclusion period;
* Patients treated with TKI during the inclusion period with a minimum of 3 year-period of TKI regular treatment before TKI discontinuation. A 3 year-period of TKI regular treatment will be defined on the presence of at least 10 TKI reimbursements per year during the 3 years preceding TKI discontinuation.

Exclusion criteria for CML population

* Patients who proceeded to allogeneic or autogenic hematopoietic stem-cell transplant (hospitalization ICD-10 code diagnosis Z94.80) in the 3 year-period prior to or in the month following the last TKI reimbursement identified before TKI discontinuation;
* Patients with HIV/AIDS (hospitalization ICD-10 code diagnosis B24) or chronic Hepatitis C or B (hospitalization ICD-10 code diagnosis B18) in the 3 year-period prior to or in the month following the last TKI reimbursement identified before TKI discontinuation;
* Recent (i.e. in the previous year) or ongoing pregnancy at TKI discontinuation date identified by an algorithm based on codes of hospitalization diagnoses and medical procedures.

Causes of TKI discontinuation will be further investigated in the cohort in order to conduct analyses only patients with a TKI discontinuation due to a complete molecular response.