Skip to content

Exploration of MRD-guided Venetoclax Bridging to Transition Continuous BTKi Therapy to Time-Limited Therapy in Chronic Lymphocytic Leukemia: A Prospective, Single-Arm, Phase 2 Study Protocol

Exploration of MRD-guided Venetoclax Bridging to Transition Continuous BTKi Therapy to Time-Limited Therapy in Chronic Lymphocytic Leukemia: A Prospective, Single-Arm, Phase 2 Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122699
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Chronic Lymphocytic Leukemia

Interventions

Experimental group:Venetoclax combined with BTK inhibitors

Sponsors

The West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed CLL (according to the 2016 World Health Organization (WHO) classification criteria for lymphoid and hematopoietic system tumors or in accordance with the 2018 International Chronic Lymphocytic Leukemia Workshop (iwCLL 2018) standards, diagnosed as CLL through histopathology and/or flow cytometry); 2. Have received BTKi (including ibrutinib, zanubrutinib and obinutinib) treatment for more than 1 year and have achieved a response (PR or better); 3. Age >= 18 years and 6 months; 5. Adequate hematological function, defined as: absolute neutrophil count (ANC) >= 1.0×10^9/L; PLT count >= 50×10^9/L; 6. Patients with basically normal liver, kidney, lung and heart functions; 7. The patient or their legal representative must provide written informed consent before undergoing any special examinations or procedures of the study.

Exclusion criteria

Exclusion criteria: 1. Comorbid with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.; 2. Other concurrent medical conditions that the subjects consider will affect their participation in the study and are not under control; 3. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol; 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Optimal MRD rate;Safety;

Secondary

MeasureTime frame
Progression Free Survival;

Countries

China

Contacts

Public ContactKai Shen

The West China Hospital of Sichuan University

453038222@qq.com+86 28 8542 3046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026