Feb. 17, 2020 |
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May. 13, 2024 |
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jRCTs041190117 |
Reattempt of tyrosine kinase inhibitor discontinuation after maintenance therapy with ponatinib in patients with chronic myeloid leukemia in the chronic phase (JALSG CML RE-STOP219) |
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Reattempt of tyrosine kinase inhibitor discontinuation after maintenance therapy with ponatinib in patients with chronic myeloid leukemia in the chronic phase (JALSG CML RE-STOP219) |
Iriyama Noriyoshi |
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Nihon University Itabashi Hospital |
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30-1 Oyaguchi Kamicho Itabashi-ku, Tokyo |
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+81-3-3972-8111 |
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iriyama.noriyoshi@nihon-u.ac.jp |
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Iriyama Noriyoshi |
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30-1 Oyaguchi Kamicho Itabashi-ku, Tokyo |
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30-1 Oyaguchi Kamicho Itabashi-ku, Tokyo |
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+81-3-3972-8111 |
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iriyama.noriyoshi@nihon-u.ac.jp |
Not Recruiting |
Feb. 17, 2020 |
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Mar. 10, 2020 | ||
45 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1) Major BCR-ABL1 positive CML-CP |
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1) Prior history of accelerated or blastic phase |
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18age old over | ||
No limit | ||
Both |
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chronic myeloid leukemia in chronic phase |
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Single-arm study in patients with CML-CP who have failed to attain a successful treatment-free remission after TKI discontinuation (defined as loss of MMR or DMR) and regained a DMR (defined as MR4.5 [less than 0.0032%] according to the International Scale). After study registration and complete screening procedures, current TKI treatment is switched to 15 mg of ponatinib. Patients who completed ponatinib therapy for 12 months (formally 52 to 58 weeks) without loss of MR4.5 can enter the treatment-free remission phase and are observed for 24 months. The trigger for TKI retreatment (either 15 mg of ponatinib or the same dose of TKI that was used before study enrollment can be selected) is defined as a loss of MMR. Patients who required retreatment with TKI are followed up to 6 months or until the achievement of MMR. |
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chronic myeloid leukemia |
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MMR rate at 12 months of ponatinib discontinuation |
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MMR/MR4.5 rate at 24 months of ponatinib discontinuation |
National Hospital Organization Review Board for Clinical Trials (Nagoya) | |
4-1-1, Sannomaru, Naka-ku Nagoya-shi, Aichi, 460-0001, Japan, Aichi | |
+81-52-951-1111 |
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311-nmc-rec@mail.hosp.go.jp | |
Approval | |
Dec. 24, 2019 |
none |