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Multicenter, prospective study of BTK inhibitor as first-line therapy for patients with treatment-naïve chronic lymphocytic leukemia (BELLATRIX)

Multicenter, prospective study of BTK inhibitor as first-line therapy for patients with treatment-naïve chronic lymphocytic leukemia (BELLATRIX)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010686
Enrollment
100
Registered
2025-06-26
Start date
2025-06-25
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 65 years or older who have provided written informed consent to participate in the study. Patients diagnosed with chronic lymphocytic leukemia (CLL) according to the 2018 iwCLL diagnostic criteria. Patients expected to initiate BTK inhibitor monotherapy within 60 days after enrollment in this study. Patients with an expected life expectancy of at least 6 months at the time of enrollment.

Exclusion criteria

Exclusion criteria: Patients with monoclonal B-cell lymphocytosis or small lymphocytic lymphoma who do not meet the iwCLL diagnostic criteria for chronic lymphocytic leukemia (CLL). Patients who have previously received any treatments for CLL other than BTK inhibitors, or those receiving BTK inhibitors in combination with other agents.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival, PFS

Secondary

MeasureTime frame
Overall Survival, OS;Objective Response Rate, ORR;Minimal Residual Disease Negativity Rate;Adverse Events, AE

Countries

Korea, Republic of

Contacts

Public ContactJongheon Jung

National Cancer Center

heony99@naver.com+82-31-920-0892

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026