TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE.

TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE. - Phase 2 study of TM5614

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029196

Enrollment

Registered

2017-09-19

Start date

2017-09-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic myelogenous leukaemia in chronic phase

Interventions

TM5614 (120mg, once a day after breakfast for 4 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient aged 18y or more 2. Signed informed consent 3. Patient with chronic phase CML and Major BCR-ABL1 transcript positivity 4. Treatment with tyrosine kinase inhibitors (TKIs) for more than 2 years overall 5. No switch between TKIs within the last 12 weeks 6. No dose modification of TKI within the last 12 weeks 7. BCR-ABLIS below 0.1% 8. BCR-ABLIS above 0.0032% 9. ECOG grade 0 to 2 10. AST and ALT below 2.5 N 11. Bilirubin in serum below 2.5 N 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 (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure - Myocardial infarction within the previous 6 months - Symptomatic cardiac arrhythmia requiring treatment - QTc above 480msec 5. Known T315I BCR-ABL kinase domain mutation 6. Patients who take Dasatinib within the last 12 weeks 7. Patients who start to take pioglitazone within the last 12 weeks 8. CML patient not in chronic phase at diagnosis 9. Individuals with an active malignancy 10. Known HIV-positivity 11. Individuals with bleeding tendency 12. 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 cumulative incidence of patients achieving DMR defined by MR4.5 or deeper (BCR-ABLIS below 0.0032 %) by 12 weeks	—

Secondary

Measure	Time frame
The transition of BCR-ABLIS in 12 weeks	—

Countries

Japan

Contacts

Public ContactHideo Harigae

Tohoku University Hospital Hematology and Rheumatology

harigae@med.tohoku.ac.jp022-717-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026