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

Phase 3

• Conditions: Chronic myelogenous leukemia in chronic phase; CML; D015464

• Registration Number: JPRN-jRCT2031220084
• Lead Sponsor: Harigae Hideo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-25
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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) <= 0.1%
(8) 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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified