ASSET-CML study

Phase 2

Recruiting

• Conditions: Chronic Myelogenous Leukemia-Chronic Phase; Chronic Myelogenous Leukemia; C921

• Registration Number: JPRN-jRCTs071230047
• Lead Sponsor: Kimura Shinya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-27
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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 2nd 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 have any of the following categories after criteria (2) above.
1) Patients who were treated with asciminib as the 3rd line or later, after resistance/intolerance to 2nd line or later TKI treatment.
2) Patients who were on TKI up to the 2nd line at criteria (2) above, and who were treated with asciminib as a 3rd line or later treatment at the discretion of the attending physician.
(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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified