Chronic lymphocytic leukemia with an indication for treatment
Conditions
Interventions
Arm A: Orelabrutinib Continuous Treatment Arm:None
Arm B: Orelabrutinib Limited-Duration Treatment Arm:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, regardless of gender. 2. Patients diagnosed with CLL/SLL according to the iwCLL 2018 criteria. 3. Presence of an indication for treatment, defined by meeting at least one of the following criteria: (1) Evidence of progressive bone marrow failure, manifested as progressive reduction in hemoglobin and/or platelet counts. (2) Massive splenomegaly (e.g., >6 cm below the left costal margin) or progressive or symptomatic splenomegaly. (3) Massive lymph nodes (e.g., longest diameter >10 cm) or symptomatic lymphadenopathy. (4) Progressive lymphocytes, defined as a >50% increase over 2 months or a lymphocyte doubling time (LDT) of =10% within the previous 6 months. 2) Significant fatigue (e.g., ECOG performance status >=2; inability to perform usual activities). 3) Fever >38.0°C for >=2 weeks without evidence of infection. 4) Night sweats for >1 month without evidence of infection. 4. No prior treatment for CLL/SLL (initiation of orelabrutinib within a maximum of 60 days prior to study enrollment is permitted). 5. The subject or their legally authorized representative voluntarily provides written informed consent before trial screening, indicating they understand the study's purpose and necessary procedures, and can comply with the protocol and follow-up requirements. 6. Willing and able to complete patient assessment questionnaires independently or with minimal assistance from caregivers and/or trained site personnel.
Exclusion criteria
Exclusion criteria: 1.Diagnosis or treatment for a malignancy other than CLL within the past year (including active central nervous system lymphoma). 2.Documented clinical evidence of Richter's transformation. 3.Life expectancy of less than 6 months. 4.Any other condition deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Next Treatment(TTNT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Overall survival(OS);Progression-Free Survival(PFS);complete remission(CR);Quality of life score;Duration of Response(DOR);adverse events(AE);Time to Treatment Failure(TTF); | — |
Countries
China
Contacts
Public ContactMi Jianqing
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed