Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) detected based on major BCR-ABL mRNA quantitative PCR assay (international scale), among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR)

Multi-center clinical study to investigate the ratio of patients who have achieved Complete Molecular Response (CMR) detected based on major BCR-ABL mRNA quantitative PCR assay (international scale), among patients with chronic myelogenous leukemia in chronic phase who achieved Major Molecular Response (MMR) - Multi-center clinical study to investigate the CMR ratio among CML-CP patients with MMR according to international scale

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004935

Enrollment

150

Registered

2011-01-24

Start date

2011-01-01

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 myelogenous leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) CML-CP patients under imatinib treatment 2) Patients with MMR* result within 3 months prior to the registration *<50 copies/assay in high sensitivity Amp-CML assay<100 copies/microg RNA (adjusted by GAPDH) or <0.1%(international scale) in RQ-PCR assay 3) 16 years old or older 4) Patients who gave written informed consent (by both a patient and a legal representative if a patient is minor)

Exclusion criteria

Exclusion criteria: 1) CML patients under treatment with combination therapy with medication other than imatinib 2) CML patients with history of treatment with tyrosine kinase inhibitor other than imatinib 3) Patients with history of hematopoietic stem cell transplantation 4) Patients with severe or uncontrollable complications 5)Patients whom a study physician judges not suitable for participation in the study

Design outcomes

Primary

Measure	Time frame
Ratio of patients who achieved CMR (<= 0.0032%) in MMR patients, defined by major BCR-ABL mRNA quantitative PCR assay (international scale)	—

Countries

Japan

Contacts

Public ContactNaoto Takahashi

Akita University School of Medicine Hematology, Oncology, Nephrology, and Rheumatology

naotot@doc.med.akita-u.ac.jp018-843-1111

Outcome results