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Exploration of Determinants of Treatment Response to Orelabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study

Exploration of Determinants of Treatment Response to Orelabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094533
Enrollment
Unknown
Registered
2024-12-24
Start date
2024-12-24
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, diagnosed with CLL/SLL. 2. Indicate treatment according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. 3. No BTK inhibitor was used in the initial or previous treatment. 4. ECOG performance status score =3 months. 6. The patient or their legal representative has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. A diagnosis or treatment of a malignant tumor other than CLL within the past year (including active central nervous system lymphoma); 2. Clinical evidence of Richter's transformation; 3. Participants cannot receive or plan to receive another investigational treatment during the study period; 4. Other conditions deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
Partial response rate;Stable disease rate;Disease progression rate;Progression free survival;Overall survival;Safety;

Countries

China

Contacts

Public ContactWenjuan Yu

The First Affiliated Hospital of Zhejiang University Medical College

drwjyu@163.com+86 135 0571 6779

Outcome results

None listed

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