Phase II randomized study of salvage therapy comparing nilotinib with dasatinib in patients with imatinib-resistant chornic phase chronic myeloid leukemia (JALSG CML210R Study)

Phase II randomized study of salvage therapy comparing nilotinib with dasatinib in patients with imatinib-resistant chornic phase chronic myeloid leukemia (JALSG CML210R Study) - Phase II randomized study of salvage therapy comparing nilotinib with dasatinib in patients with imatinib-resistant chornic phase chronic myeloid leukemia (JALSG CML210R Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003616

Enrollment

Registered

2010-05-20

Start date

2010-06-01

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

imatinib-resistant chornic phase chronic myeloid leukemia

Interventions

nilotinib dasatinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Imatinib-resistant chornic phase chronic myeloid leukemia 2.PS 0-2 (ECOG) 3.Adequate hepatic, renal, pulmonary and cardiac function 4.Not having the BCR-ABL mutations (T315I, V299L, F317L, Y253H, E255K/V, F359V) 5.Written informed consent 6.Not determined enforcement of hematopoietic stem cell transplantation during registration

Exclusion criteria

Exclusion criteria: 1.Other active neoplasms 2.Severe infection 3.Uncontorlled diabetis meritis 4.Severe psychological disorders such as shizophrenia 5.Pregnant and/or lactating woman 6.Accelerated phase or blast crisis chronic myeloid leukemia 7.Medication of nilotinib or dasatinib in the past 8.Taking oral medicine having the possibility of extending QT interval 9.Taking medicine inhibiting platelet function or anticoagulant 10.History of bleeding disorder 11.Having the BCR-ABL mutations(T315I, V299L, F317L, Y253H, E255K/V, F359V) in the past 12.History of interstitial lung disease 13.History of ischemic heart disease, congestive heart failure or arrhythmias requiring treatment 14.History of pancreatitis 15.History of intravenous bisphosphonates within 8 weeks

Design outcomes

Primary

Measure	Time frame
Rate of treatment success at 2 years	—

Secondary

Measure	Time frame
1) Overall survival and progression free survival at 2 years, 2) Rate of achieving a major molecular response at 2 years, 3) Frequency of grade 3 and more adverse events	—

Countries

Japan

Contacts

Public ContactKatsumichi Fujimaki

Fujisawa City Hospital Department of Hematology and Immunology

kkfujimaki@gmail.com0466-25-3111

Outcome results

None listed

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