This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib monotherapy , sequential Zanubrutinib combined (Fludarabine, cyclophosphamide and rituximab /bendamustine and rituximab)FCR/BR regimen by a limited period of treatment for the newly diagnosed Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The investigators propose this combination will improve the MRD negative rate of patients with CR/CRi after treatment was significantly higher than that of FCR chemotherapy can be a time-limited regimen which will reduce the life-time therapy and benefit the patients.
The investigators designed timed FCR/BR treatment for BTK inhibitor Zanubrutinib monotherapy after continuous remission, which shortened the treatment time, deepened the depth of remission, and enabled some patients to achieve deep remission (MRD negative), and realized long-term survival after drug withdrawal. Treatment regimens: Zanubrutinib monotherapy for 12 months followed by 4 courses of immunochemotherapy with FCR or BR. Cohort 1 was designed to apply FCR for patients aged 65 years or younger who could tolerate FCR. Cohort 2 was designed to apply BR in patients older than 65 years or unable to tolerate FCR.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Patients aged 65 years or younger who can tolerate FCR.
For patients older than 65 years or who cannot tolerate FCR regimens.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
MRD negative rate of CR patients
The negative MRD rate of patients with CR at the end of 16 cycles of treatment
Time frame: up to the end of 16 cycles of treatment (each cycle is 28 days)
overall response rate(ORR)
Defined as the proportion of patients whose BICR was assessed for CR, CRi, or PR according to IWCLL 2018 criteria at or before initiation of subsequent antitumor therapy.
Time frame: up to the end of 16 cycles of treatment (each cycle is 28 days)
Complete response (CR)
Defined as the percentage of subjects who achieved CR after treatment in the conformance population and the intentionality treatment population.
Time frame: up to the end of 16 cycles of treatment (each cycle is 28 days)
Duration of tumor remission(DOR)
Defined as the time interval between the first documented remission of disease and the first documented evidence of PD for patients in the intentional-treatment population (ITT). Exit with no progress or no recorded time of disease progression, with the date of the last examination as the end date.
Time frame: up to 5 years
time to next treatment(TTNT)
Patients in the treatment-intentionality population (ITT) were defined from the beginning of first-line treatment to the beginning of back-line treatment or the time of death.
Time frame: up to 5 years
Progress-free survival(PFS)
the time from treatment initiation until disease progression or death, If there was no progress at the time of withdrawal or the time of disease progression was not recorded, the end date was the date of the last examination.
Time frame: up to 5 years
The time at which the median MRD turned positive
It was defined as the time for the median peripheral and/or bone marrow MRD to become positive in patients with CR/CRi and MRD negative in bone marrow and peripheral blood after the 16th cycle of treatment.
Time frame: up to 5 years
overall survival
Defined as the time interval from enrollment to death for patients in the treatment-intentionality population (ITT). If the patient remains alive or if it is not known whether the patient is alive or dead, the date of death will be adopted at the most recent point in time when the patient is known to be alive.
Time frame: up to 5 years
Safety of treatment regimens
Defined as treatment-related toxicity
Time frame: up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.