Phase 3, randomized, double-blind study of the efficacy of TM5614 in combination with tyrosine kinase inhibitors in chronic phase chronic myelogenous leukemia patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220084

Enrollment

Registered

2022-05-25

Start date

2022-07-29

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic myelogenous leukemia in chronic phase CML

Interventions

TM5614 (180mg, once a day orally for more than 48 weeks, until the day before the last visit)

D000284

Drug Therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patient aged 18y or older (2) Signed informed consent (3) Patient with Philadelphia chromosome positive chronic phase CML and Major BCR-ABL1 transcript positivity (4) Treatment with imatinib, nilotinib, dasatinib or bosutinib for more than 3 years and less than 6 years (5) No switch between TKIs within the last 12 weeks (6) No dose modification of TKI within the last 12 weeks (7) BCR-ABL(IS) 0.0032% (9) ECOG PS grade 0 to 2 (10) AST and ALT <= 2.5 times the upper limit of the reference value (11) Bilirubin in serum <= 2.5 times the upper limit of the reference value (12) Men and Women of childbearing potential must be using an adequate method of contraception

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women (2) Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment, (3) Prior history of hematopoietic stem cell transplantation (autologous or allogenic) (4) Cardiovascular disease: - Stage II to IV congestive heart failure as determined by the NYHA classification system for heart failure - Myocardial infarction within the previous 6 months - Symptomatic arrhythmias that need treatment (5) Known T315I BCR-ABL kinase domain mutation (6) CML patient not in chronic phase at diagnosis (7) Patients with an active malignancy (8) Known HIV-positivity (9) Patients with bleeding tendency (10) Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study

Design outcomes

Primary

Measure	Time frame
The DMR maintenance rate for 96 weeks of patients achieving DMR defined by MR4.5 (BCR-ABL(IS) <= 0.0032 %)	—

Secondary

Measure	Time frame
-The cumulative incidence of patients achieving DMR defined by MR4.5 (BCR-ABL(IS)<= 0.0032 %) by 48 weeks -The transition of BCR-ABL(IS)	—

Contacts

Public ContactClinical Trial Coordinating Office

CTD Inc.

tm5614cml@c-ctd.co.jp+81-3-6228-4835

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026