To hear about similar clinical trials, please enter your email below
Trial Title:
Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
NCT ID:
NCT06503263
Condition:
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lenalidomide
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zanubrutinib plus Lenalidomide as Maintenance Therapy
Description:
Patients were treated by Zanubrutinib(160mg po bid d1-28) plus Lenalidomide(25mg po qd
d1-14) as maintenance therapy until 2 years post chemotherpay
Arm group label:
Maintenance Therapy
Other name:
Zanubrutinib plus Lenalidomide
Summary:
The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and
lenalidomide as maintenance therapy in patients with DLBCL.
Detailed description:
The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as
maintenance therapy in patients with diffuse large B-cell lymphoma post complete
remission and have completed planed courses of chemotherapy . Event-free survival (EFS),
progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be
assessed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health
Organization (WHO) classification;
- Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Patient must understand and voluntarily sign an ICF prior to any study-specific
assessments/procedures being conducted;
- Patient is willing and able to adhere to the study visit schedule and other protocol
requirements;
- Patient has recieved complete remission and has completed planed courses of
chemotherapy
- Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10^9/L (≥ 1
x 10^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10^9/L (≥ 50 x
10^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life
expectancy at least 3 months
Exclusion Criteria:
- Active or uncontrolled infections requiring systemic treatment within 14 days before
enrollment;
- Any instability of systemic disease, including but not limited to severe cardiac,
liver, kidney, or metabolic disease need therapy;
- Pregnant or lactating women
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Navy General Hospital
Address:
City:
Beijing
Zip:
100048
Country:
China
Status:
Recruiting
Contact:
Last name:
Liren Qian, M.D.
Phone:
+861066947194
Email:
qlr2007@126.com
Start date:
August 30, 2024
Completion date:
December 30, 2030
Lead sponsor:
Agency:
Navy General Hospital, Beijing
Agency class:
Other
Source:
Navy General Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503263
