A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)

A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study) - A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007909

Enrollment

450

Registered

2012-05-08

Start date

2012-05-01

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

Interventions

Nilotinib Dasatinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed chronic myeloid leukemia in chronic phase 2. PS 0-2 (ECOG) 3. Adequate hepatic, renal, pulmonary, pancreatic, and cardiac function 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. History of the treatment with the tyrosine kinase inhibitor except for imatinib within two weeks 2. Registered case in the other clinical trial 3. Detected T315I mutation in the BCR-ABL gene 4. History of allogenic hematopoietic stem cell transplantation 5. Impaired cardiac function 6. Other active neoplasms 7. Active infection requiring the treatment 8. Pregnant and/or lactating woman 9. Severe psychiatric disorders 10. Severe or uncontrolled comorbidities (diabetes, etc.)

Design outcomes

Primary

Measure	Time frame
Cumulative achievement of CMR by 18 months	—

Secondary

Measure	Time frame
Efficacy (Cytogenetic Response, Molecular Response) PFS Safety Continuity	—

Countries

Japan

Contacts

Public ContactItaru Matsumura

Kinki University, Faculty of Medicine Department of Hematology and Rheumatology

i.matsu@med.kindai.ac.jp072-366-0221

Outcome results

None listed

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