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The Observational Study of De Novo Chronic Myeloid Leukemia Patients in Chronic Phase in Japan

The Observational Study of De Novo Chronic Myeloid Leukemia Patients in Chronic Phase in Japan - The New Target Observational Study 1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000003581
Enrollment
500
Registered
2010-05-10
Start date
2010-04-01
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

Chronic Myeloid Leukemia

Interventions

None listed

Sponsors

The Japanese Society of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)CML-CP patients with none of the following signs of accelerated or blast phase CML: - Blasts more than 15% of peripheral blood white cells or bone marrow cells - Combined blast/promyelocyte count more than 30% in peripheral blood or bone marrow - Peripheral blood basophiles more than 20% - Extramedullary lesions other than hepato-splenomegaly 2)Patients who have given written informed consent to the study; informed consent must also be obtained from the legal representative of every patient under 20 years of age. 3)Patients who will be able to make visits to a study site as scheduled.

Exclusion criteria

Exclusion criteria: 1)Patients previously treated with any investigational drug for CML. 2)Patients previously treated with IFN-alpha. 3)Patients previously receiving any oral cytotoxic drug (e.g., hydroxyurea) for at least 3 months. 4)Women with confirmed or potential pregnancy, nursing mothers, and male or female patients who wish to have a child during the study period. 5)Patients with a history of allergy to imatinib. 6)Patients with any concomitant illness that contraindicates use of imatinib. 7)Patients with any other condition that, in the investigator's opinion, disqualifies them for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS) rate at 5 years after the first diagnosis of CML.

Countries

Japan

Contacts

Public ContactItaru Matsumura

Kinki University School of Medicine Division of Hematology, Department of Internal Medicine

072-366-0221

Outcome results

None listed

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