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Efficacy and safety of patients with chronic myeloid leukemia who had been treated with at least two TKIs for more than 18 months and failed to reach MMR, switched to olverembatinib or continued the original TKI treatment: a prospective, superiority randomized controlled clinical study

Efficacy and safety of patients with chronic myeloid leukemia who had been treated with at least two TKIs for more than 18 months and failed to reach MMR, switched to olverembatinib or continued the original TKI treatment: a prospective, superiority randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072680
Enrollment
Unknown
Registered
2023-06-21
Start date
2023-06-23
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

chronic myeloid leukemia

Interventions

1:Olverembatinib
2:original TKI therapy (Nilotnib, Dasatnib)

Sponsors

The Second People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: • Age = 18 years and =75 years. • Diagnosis of CML-CP. • Patients who have received at least two TKIs (nilotinib/ dasatinib/ flumatinib) for more than 18 months and have not reached MMR. • Willing to try to discontinue TKI in the future to achieve treatment free remission(TFR) • ECOG performance of 0-2.

Exclusion criteria

Exclusion criteria: • T315I mutation of BCR-ABL; • Known to be allergic to study drug ingredients or their analogues. • Patients with other malignant tumor under treating. • Patients with a history of severe heart disease, severe liver and kidney dysfunction, or a history of severe hemorrhagic disease. • Patients with unclear consciousness or Mental disorder cannot cooperate with diagnosis and treatment; • Pregnant or breast-feeding patients. • Researchers have evaluated patients who are deemed unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
the rate of MMR at 6 months;

Secondary

MeasureTime frame
The proportion of patients with MMR at 3, 9,12 months.;The proportion of patients with MR 4.0 at 3, 6, 9, 12 months;The proportion of patients with MR 4.5 at 3, 6, 9, 12 months;

Countries

China

Contacts

Public ContactBingbing Wen

The Second People's Hospital of Shenzhen

332472614@qq.com+86 187 1857 5496

Outcome results

None listed

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