Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study) - Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000153

Enrollment

300

Registered

2005-09-10

Start date

2002-04-01

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+Interferon-alpha Imatinib+Cytarabine ocfosfate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic phase CML (Ph+ or BCR-ABL+) previously untreated with IFN 2. Age: 15=< 3. PS 0-3 (ECOG) 4. No severe organ dysfunction 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Other active neoplasms 2. Severe comorbidity 3. Hypersensitivity to imatinib 4. Previously treated with IFN 5. Psychological disorders 6. Pregnant and/or lactating woman 7. CML in accelerated phase or blast crisis

Design outcomes

Primary

Measure	Time frame
1) Imatinib monotherapy: overall survival 2) Combination therapy: cytogenetic response at 9 months	—

Secondary

Measure	Time frame
1) Imatinib monotherapy: toxicity, hematologic response at 6 months, cytogenetic response at 9 months, progression free survival, time to treatment failure 2) Combination therapy: toxicity, hematologic response, cytogenetic response, overall survival, progression free survival, time to treatment failure	—

Countries

Japan

Contacts

Public ContactKazunori Ohnishi

JALSG CML202 Study Office Hamamatsu University School of Medicine, Division of Clinical Oncology

jalsgsc@hama-med.ac.jp053-433-4993

Outcome results

None listed

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