Chronic Myelogenous Leukemia-Chronic Phase Chronic Myelogenous Leukemia
Conditions
Interventions
Asciminib (Scemblix) will be administered within the approved dosage and administration in Japan (the usual adult dosage is 80 mg of asciminib orally once daily on an empty stomach. The dose will be r
discontinuation of asciminib
Sponsors
Ureshino Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pre-Registration Inclusion Criteria Patients with Chronic Myelogenous Leukemia-Chronic Phase(CML-CP) who satisfy all of the following criteria. (1) Patients without extramedullary leukemia, except for hepatomegaly and splenomegaly mass. (2) Patients with molecular genetic relapse (MMR loss: BCR-ABL1 mRNA IS > 0.1% by RQ-PCR) despite discontinuation of Tyrosine Kinase Inhibitor(TKI) after achieving DMR (MR4.0 or MR4.5: BCR-ABL1 mRNA IS =<0.01% or =<0.0032% by RQ-PCR) of at least 1 year with 1st line or later TKI treatment.*1 *1) In principle, molecular relapse (loss of MMR) is the standard, but patients who restarted treatment due to loss of DMR at the discretion of a doctor are also included. (3) Patients who were treated with asciminib as the 2nd line or later. (4) Patients with DMR (MR4.5: BCR-ABL1 mRNA IS =<0.0032% by RQ-PCR) after criteria (3) above. (5) Patients 18 years or older at pre-registration. (6) Patients with ECOG PS score of 0-2. (7) Patients who are judged by the investigator or sub-investigator that the functions of major organs (liver, kidneys and lungs) are maintained. (8) Patients with written consent. 2. Official Registration Inclusion Criteria (1) Patients who confirmed two consecutive DMR (MR4.5). (2) Patients whose written consent was already obtained at pre-registration.
Exclusion criteria
Exclusion criteria: Patients who fall under any of the following criteria will not be selected as the subjects of this study. (1) Patients with active double cancer. (2) Patients who are in pregnancy or under breast feeding. (3) Patients with a history of hypersensitivity to asciminib hydrochloride. (4) Patients with a history of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis. (5) Patients who are deemed to be ineligible for the study by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TFR rate at 12 months after discontinuation of asciminib treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Indicators of protocol treatment efficacy. - TFR rate at 24 months after discontinuation of asciminib treatment. - Overall survivals. (2) Remission rates (MR4.5 and MR4.0) at the time of re-administration due to MMR loss after discontinuation of asciminib treatment. (3) Examination of factors associated with TFR. - Total duration of TKI administration - Total duration of TKI + asciminib administration - Duration of DMR induction - Total dose of asciminib during DMR (for 24 months) - Duration from last discontinuation to relapse - Peripheral blood marker expression profiles such as T/NK/Treg and lymphocyte subsets by flow cytometry - Sokal score, Hasford score, ELTS score at the time of CML diagnosis - Gender (4) PRO (using the Japanese version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3.0) attached to the study protocol). (5) AEs during protocol treatment (after pre-registration). | — |
Contacts
Public ContactHiroshi Ureshino
Faculty of Medicine, Saga University
Outcome results
None listed