A single-arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment

A single-arm, multicenter, nilotinib treatment-free remission study in patients with BCRABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment - CAMN107I2201

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222102

Enrollment

Registered

2013-06-10

Start date

2013-05-07

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 Leukemia

Interventions

All patients will be treated with 300 mg BID nilotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria 1) Minimum of 2 calendar years of nilotinib treatment for BCR-ABL positive CML in documented chronic phase at the time of diagnosis 2) Documented chronic phase CML 3) Patient in MR4.5 at prescreening at Novartis designated lab 4) ECOG performance status 0-2 5) Adequate bone marrow and organ function meeting laboratory criteria

Exclusion criteria

Exclusion criteria: Main exclusion criteria 1) Previous treatment with BCR-ABL inhibitors other than nilotinib for more than a total cumulative duration of 4 weeks 2) Previous treatment with alpha-interferon of any duration 3) Previous anticancer agents for CML other than nilotinib 4) Known second chronic phase of CML after previous progression to AP/BC 5) Severe and/or uncontrolled concurrent medical disease 6) History of another active malignancy within 5 years prior to study entry 7) Pregnant or nursing (lactating) women

Design outcomes

Primary

Measure	Time frame
efficacy To determine the percentage of patients who are in MMR at 48 weeks after starting the treatment-free remission (TFR) phase	—

Secondary

Measure	Time frame
efficacy To determine the percentage of patients who are in MR4.5, To determine the percentage of patients who are in MMR, To characterize the kinetics of BCR-ABL transcript after re-start of nilotinib therapy, TFS, PFS, OS, safety, BCR-ABL mutation	—

Countries

Argentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

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