DAsatinib DIscontinuation for 1st-Line treatment with Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remission

Conditions

chronic myeloid leukemia

Ureshino H, Ueda Y, Fujisawa S, Usuki K, Tanaka H, Okada M, Kowata S, Murai K, Hirose A, Shindo M, Kumagai T, Takeoka T, Kamachi K, Kidoguchi K, Shindo T, Iyama S, Inamura J, Nakao T, Kobayashi T, Kawata E, Ohkawara H, Ikezoe T, Kawaguchi A, Kimura S.

2024-02-093 citations

10.1016/j.bneo.2024.100001

Treatment-free remission after first-line dasatinib discontinuation in patients with chronic myeloid leukaemia (first-line DADI trial): a single-arm, multicentre, phase 2 trial.

Kimura S, Imagawa J, Murai K, Hino M, Kitawaki T, Okada M, Tanaka H, Shindo M, Kumagai T, Ikezoe T, Uoshima N, Sato T, Watanabe R, Kowata S, Hayakawa M, Hosoki T, Ikeda K, Kobayashi T, Kakinoki Y, Nishimoto T, Takezako N, Shibayama H, Takaori-Kondo A, Nakamae H, Kawaguchi A, Ureshino H, Sakamoto J, Ishida Y, DADI Trial Group.

2020-01-2171 citations

10.1016/s2352-3026(19)30235-2

PF407 TREATMENT‐FREE REMISSION IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA FOLLOWING FIRST‐LINE DASATINIB, 1ST DADI/IMIDAS4

Kazunori Murai, Shinya Kimura, Jun Imagawa, Masayuki Hino, Toshio Heike et al. (28 authors)

HemaSphere2019-06-01

10.1097/01.hs9.0000559840.07660.1c

Interventions

Discontinuation of dastinib in patients with 1st line treatment with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who has been treated by Dasatinib as 1st line treatment at least 24 months with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year. 2. ECOG performance status (PS) score 0-2 3. Adequate hepatic, renal and lung function 4. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients who have been treated by TKI except Dasatinib or Interferon.(except patients who have treated by Imatinib within 4 weeks as an ex-treatment.) 2. Concurrent malignancy other than CML 3.Women who are pregnant or breastfeeding 4.A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Design outcomes

Primary

Measure	Time frame
Molecular relapse free survival rate after discontinuation of dastinib at 6 months.	—

Secondary

Measure	Time frame
Molecular relapse free survival rate after discontinuation of dastinib at 12 months. We assessed LGL expansions, dose of dasatinib and time to CMR, total dose of dasatinib in last 12 months during CMR, metods and, sex and sokal risk group as potential prognostic factors for molecular relapse free survival. Molecular remission rate after dasatinib re-challenge in cases of molecular relapse.	—

Countries

Japan

Contacts

Public ContactShinya Kimura

1st DADI/IMIDAS4th -Trial Group Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga Univ.

shkimu@cc.saga-u.ac.jp0952-34-2353

Outcome results

None listed