Dasatinib discontinuation for 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

Discontinuation of dasatinib in patients with chronic myeloid leukaemia who have maintained deep molecular response for longer than 1 year (DADI trial): a multicentre phase 2 trial.

Imagawa J, Tanaka H, Okada M, Nakamae H, Hino M, Murai K, Ishida Y, Kumagai T, Sato S, Ohashi K, Sakamaki H, Wakita H, Uoshima N, Nakagawa Y, Minami Y, Ogasawara M, Takeoka T, Akasaka H, Utsumi T, Uike N, Sato T, Ando S, Usuki K, Morita S, Sakamoto J, Kimura S, DADI Trial Group.

2015-11-10250 citations

10.1016/s2352-3026(15)00196-9

Discontinuation Of Dasatinib In Patients With CML Who Have Maintained Complete Molecular Response For At Least One Year: Results From a Prospective Discontinuation (DADI) Trial

Hideo Tanaka, Jun Imagawa, Masaya Okada, Hirohisa Nakamae, Masayuki Hino et al. (21 authors)

Blood2013-11-159 citations

10.1182/blood.v122.21.3998.3998

Interventions

Discontinuation of dasatinib in patients with Chronic Myelogenous Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with Chronic Myelogenous Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year. 2. ECOG performance status (PS) score 0-2 3. Adequate organ function (hepatic, renal and lung) 4. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1. Concurrent malignancy other than CML 2.Women who are pregnant or breastfeeding 3. A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy 4.Subjects with T315I, F317L and V299L BCR-ABL point mutations 5.Subjects with clonal evolution

Design outcomes

Primary

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

Secondary

Measure	Time frame
1)Molecular relapse free survival rate after discontinuation of dasatinib at 12 months. 2)Evaluate potential prognostic factors for molecular relapse free survival. i)We assessed LGL expansions, ii)dose of dasatinib and time to CMR, iii)total dose of dasatinib in last 12 months during CMR, iv)methods and response of previous therapy, v)previous interferon therapy, vi)sex vii) sokal risk group 3)Molecular remission rate after dasatinib re-challenge in cases of molecular relapse.	—

Measure

Time frame

1)Molecular relapse free survival rate after discontinuation of dasatinib at 12 months. 2)Evaluate potential prognostic factors for molecular relapse free survival. i)We assessed LGL expansions, ii)dose of dasatinib and time to CMR, iii)total dose of dasatinib in last 12 months during CMR, iv)methods and response of previous therapy, v)previous interferon therapy, vi)sex vii) sokal risk group 3)Molecular remission rate after dasatinib re-challenge in cases of molecular relapse.

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Countries

Japan

Contacts

Public ContactShinya Kimura

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

shkimu@cc.saga-u.ac.jp

Outcome results

None listed