Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory Diffuse Large B Cell Lymphoma, a Multicenter, Open and Prospective Clinical Trial

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    20
  • sponsor
    Qingdao Central Hospital
Updated on 7 June 2022

Summary

This clinical trial is an investigator-initiated multicenter, open, prospective clinical study in order to explore the efficacy and safety of rituximab plus zanubrutinib and lenalidomide in relapsed and refractory diffuse large B cell lymphoma.

Description

Subjects are patients withRelapsed and refractory Diffuse Large B cell lymphoma (DLBCL). All included patients will be treated with rituximab plus zanubrutinib and lenalidomide. In the induction stage, patients will receive 375 mg/m2 rituximab Day 1 of Cycles 1-6, twice-daily 160 mg zanubrutinib and 25 mg lenalidomide Days 1-21 of each 28-day cycle. In the maintenance treatment period, patients will receive 375 mg/m2 rituximab every 2 months, twice-daily 160 mg zanubrutinib and 10 mg lenalidomide Days 1-21 of each 28-day cycle. Imaging evaluation will take every two cycles to determine the best therapeutic effect, PD patients will exit from the clinical trial. The comprehensive therapeutic evaluating will take after 4 cycles. Peripheral blood stem cells can be collected from young patients with PR or CR. If patients' condition is suitable after 6 cycles of induction therapies, autologous hematopoietic stem cell transplantation can be chosed for patients with PR or CR and exit from the trail.Primary study endpoint is objective response rate (ORR) at the end of 6 cycles of induction therapy. Secondary study endpoints include progression-free survival time (PFS), overall survival (OS) and adverse reaction events (TEAS). After sample size calculation, we plan to enroll 72 relapsed and refractory diffuse large B cell lymphoma patients.

Details
Condition Overall Survival
Treatment Rituximab + zanubrutinib + lenalidomide
Clinical Study IdentifierNCT05392257
SponsorQingdao Central Hospital
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

) adequately treated carcinoma in situ
of the cervix; 2) Local basal cell carcinoma or squamous cell carcinoma of the skin; 3)
Pre-existing malignant disease that has been controlled and treated locally and radically
(surgically or otherwise)
.Have clinically significant cardiovascular disease, including: 1) myocardial infarction
that occurred within 6 months prior to screening stage; 2) Unstable angina pectoris within
months before screening stage; 3) Clinical major arrhythmia (e.g., persistent ventricular
tachycardia, ventricular fibrillation, tachycardia with torsional tip); 4) QTcF (corrected
according to Fridericia formula) >480 msec; 5) History of second-degree type II
atrioventricular block or third-degree ATrioventricular block; 6) Class III or IV
congestive heart failure as defined by the New York Heart Association (NYHA)
.History of severe hemorrhagic disease, such as hemophilia A, hemophilia B, von willebrand
disease, or history of spontaneous bleeding requiring blood transfusion or other medical
intervention
.History of stroke or intracranial hemorrhage within 6 months prior to the first taking of
the investigational drug
.Inability to swallow capsules or a medical condition that significantly affects
gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel
resection, symptomatic inflammatory bowel disease, or partial or complete intestinal
obstruction; 11.Uncontrolled systemic infection requiring intravenous administration of
drugs for parenteral anti-infective therapy
.Human immunodeficiency virus (HIV) infection, or presence of serological status of
active hepatitis B or C virus infection: 1)Either hepatitis B surface antigen (HBsAg)
positive or hepatitis B core antibody (HBcAb) positive serology can be enrolled if
hepatitis B virus (HBV) DNA (<20 IU/mL) and are willing to receive monthly HBV reactivation
monitoring. 2) For patients in the presence of hepatitis C virus antibody, they could be
enrolled if HCV RNA is not detected
.Hypersensitivity is known to either lenalidomide or rituximab, or to chemical or
biological analogues of lenalidomide and rituximab
.Women during pregnancy or lactation. 15.Any life-threatening disease, medical condition
or incomplete organ system as considered by the investigator that may affect the safety of
the subject or lead to the study risk
.History of deep venous thrombosis (DVT) or pulmonary embolism (PE) in the past 12
months

Exclusion Criteria

.Special type of lymphoma: primary mediastinal (thymus) large B cell
lymphoma
.Patients with other hematological diseases and non-lymphoma were diagnosed. 3.Other
active malignancies that require concurrent treatment. 4.Major surgery is performed within
weeks before screening. 5.Previous anticancer therapy toxicity is still equal to or more
than grade 2 when enrol (except for alopecia, ANC, hemoglobin and platelet toxicity); ANC
hemoglobin and platelet-related requirements, please follow the inclusion criteria 9
.History of other active malignant diseases within 2 years prior to study entry, but the
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