Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Interventions
Combination Therapy Group:Bendamustine + Rituximab + Orelabrutinib
Monotherapy Group:Physician's Choice of BTK Inhibitor
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all the following eligibility criteria to be included in this trial: 1.Aged >=18 years, with no gender restrictions; 2.Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria; 3. Have indications for treatment, mainly including (at least one of the following conditions): (1) Evidence of progressive bone marrow failure: manifested as progressive reduction in hemoglobin and/or platelets; (2)Massive splenomegaly (e.g., >6cm below the left costal margin) or progressive or symptomatic splenomegaly; (3)Giant lymph node enlargement (e.g., longest diameter >10cm) or progressive or symptomatic lymph node enlargement; (4)Progressive lymphocytosis, such as an increase in lymphocytes by >50% within 2 months, or lymphocyte doubling time (LDT) =10% in the past 6 months; Severe fatigue (e.g., ECOG performance status >=2 points; unable to perform routine activities); Temperature >38? for >=2 weeks without evidence of infection; Night sweats for >1 month without evidence of infection; 4. ECOG performance score of 0-3 points; 5. Patients are untreated or have not undergone standard treatment for the first time, with specific conditions as follows: (1) Have not been treated with bendamustine-containing or rituximab-containing regimens; (2) Have not been treated with ibrutinib, or have used ibrutinib for less than 4 weeks (alone or in combination with adrenal glucocorticoids); (3)If the above treatments have been used, they must stop treatment for 2 weeks before they can be enrolled and start treatment; 6. Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and can comply with the protocol and follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible to participate in this study: 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 experimental treatment during their participation in the study; 4.Any other circumstances deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Next Treatment or Death at 30 Months (30 month TTNT);Time to Treatment Failure (TTF); | — |
Secondary
| Measure | Time frame |
|---|---|
| 15-month Treatment Compliance;Progression-Free Survival (PFS);Undetectable Minimal Residual Disease (uMRD);Minimal Residual Disease Reduction Rate (?MRD);Complete Response Rate (CR);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactDing Kaiyang
Anhui Provincial Cancer Hospital
Outcome results
None listed