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Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study)

Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study) - Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive-one (JALSG CML207study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000823
Enrollment
240
Registered
2007-09-15
Start date
2007-06-01
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

Previously untreated Chronic-phase chronic myelogenous leukemia

Interventions

imatinib imatinib

Sponsors

Japan Adult Leukemia Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Previously untreated chronic phase CML 2. Age: 15=< <70 3. PS 0-3 (ECOG) 4. No severe major organ dysfunction 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Other active neoplasma 2. Severe infection 3. Anticancer drug other than hydoroxurea in 2 weeks 4. Severe psychological disorders such as shizophrenia 5. Pregnant and/or lactating woman 6. Uncontorlled diabetis meritis 7. Acute myocardial infarction in 1 year or history of heart failure 8. Liver chirosis 9. Otherwise eligible

Design outcomes

Primary

MeasureTime frame
Molecular response at 12 months of imatinib therapy

Secondary

MeasureTime frame
1 Overall survival at three years 2 Cytogenetic response at 2 years 3 Adverse events grade 3 and more

Countries

Japan

Contacts

Public ContactKoichi Miyamura

Japanese Red Cross Nagoya First Hospital Department of hematology

miyamu@nagoya-1st.jrc.or.jp052-481-511

Outcome results

None listed

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