Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Amino Acids

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Zanubrutinib

Bendamustine Hydrochloride

Rituximab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients aged 65 years or younger who can tolerate FCR： Patients in this group will receive zanubrutinib monotherapy for 12 months, then receive 4 cycles of zanubrutinib, fludarabine, cyclophosphamide and rituximab(ZFCR). Efficacy evaluation and MRD test of peripheral blood and bone marrow were performed at the 17th cycle after 16 cycles to obtain study end point data. Patients with CR/CRi and MRD negative could stop taking zanubrutinib, and other patients could stop taking zanubrutinib or continue treatment. Follow-up and efficacy assessment were conducted every three months.

For patients older than 65 years or who cannot tolerate FCR regimens: Patients in this group will receive zanubrutinib monotherapy for 12 months, then receive 4 cycles of bendamostine and rituximab(BR). Efficacy evaluation and MRD test of peripheral blood and bone marrow were performed at the 17th cycle after 16 cycles to obtain study end point data. Patients with CR/CRi and MRD negative could stop taking zanubrutinib and other patients could stop taking zanubrutinib or continue treatment.

Patients aged 65 years or younger who can tolerate FCR.

Zanubrutinib, Fludarabine, cyclophosphamide and rituximab

For patients older than 65 years or who cannot tolerate FCR regimens.

Zanubrutinib, bendamustine, rituximab

Shuhu Yi

Lugui Qiu

Shuhua Yi

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.

Zanubrutinib Followed Zanubrutinib Plus FCR / BR in Newly Diagnosed Symptomatic CLL/SLL

A Phase 2 Clinical Trial to Evaluate the Efficacy of Zanubrutinib Followed Zanubrutinib Plus FCR (Fludarabine Cyclophosphamide and Rituximab) / BR(Bendamustine and Rituximab) in Newly Diagnosed Symptomatic CLL/SLL (STOP Trial)

To explore the effects of different biological factors on treatment response, MRD negative and survival.

The negative MRD rate of patients with CR at the end of 16 cycles of treatment

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.

Defined as the percentage of subjects who achieved CR after treatment in the conformance population and the intentionality treatment population.

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.

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.

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.

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.

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.

Spots Global Cancer Trial Database for zanubrutinib, bendamustine, rituximab