Skip to content

Multicenter prospective trial after first or second unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular remission after stopping TKI 2nd or 3rd time

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519472-69-00
Acronym
CAMN107ADE22T
Enrollment
75
Registered
2024-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-27

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

Conditions

CML-Patients in chronic phase having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not and are pretreated at least one year with any TKI after 1st stop

Brief summary

The primary endpoint is molecular relapse-free survival, measured at 12 months and 36 months after 2nd or 3rd stop.

Detailed description

overall survival and progression-free survival probabilities, Estimation of the number of patients in MR4.5 who would be eligible for stopping TKI therapy, The number of patients who regain MR4 and MR4.5 and the time to MR4 recovery, Outcome of molecular relapse-free survival at 12, 18, 24 and 36 months after TKI discontinuation

Interventions

Sponsors

Heidelberg University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is molecular relapse-free survival, measured at 12 months and 36 months after 2nd or 3rd stop.

Secondary

MeasureTime frame
overall survival and progression-free survival probabilities, Estimation of the number of patients in MR4.5 who would be eligible for stopping TKI therapy, The number of patients who regain MR4 and MR4.5 and the time to MR4 recovery, Outcome of molecular relapse-free survival at 12, 18, 24 and 36 months after TKI discontinuation

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026