To hear about similar clinical trials, please enter your email below
Trial Title:
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
NCT ID:
NCT06471738
Condition:
Ann Arbor Stage II Follicular Lymphoma
Grade 1 Follicular Lymphoma
Ann Arbor Stage III Follicular Lymphoma
Ann Arbor Stage IV Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Rituximab
Venetoclax
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
BTK inhibitor
Arm group label:
Treatment (zanubrutinib, venetoclax, rituximab)
Intervention type:
Biological
Intervention name:
Rituximab
Description:
Monoclonal antibody to CD20
Arm group label:
Treatment (zanubrutinib, venetoclax, rituximab)
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
BCL-2 inhibitor
Arm group label:
Treatment (zanubrutinib, venetoclax, rituximab)
Summary:
This is a single center, open label, single arm phase II clinical trial. The objective of
this study is to assess the feasibility and efficacy of zanubrutinib combined with
venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .
Detailed description:
Follicular lymphoma (FL)is the most common inert non Hodgkin's lymphoma (iNHL). Their
natural courses are slow but highly variable. The standard first-line treatment of
advanced FL is based on rituximab. Whether combined with chemotherapy or not, it can
induce lasting remission, but it is usually incurable. Although the first-line
immunochemotherapy regimen has high efficacy, it also has high toxicity. Cytotoxic
chemotherapy is related to many side effects, including bone marrow suppression and
immunosuppression, gastrointestinal and cardiac toxicity, neurotoxicity and the
occurrence of secondary tumors. About 20% of FL patients relapse within 2 years after
first-line chemotherapy. The overall prognosis of these patients is poor. This clinical
trial aims to evaluate the feasibility and efficacy of free-chemotherapy regimen
(zanubrutinib combined with venetoclax and Rituximab) in patients with previously
untreated follicular lymphoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
- Stage II, III, or IV disease
- Able and willing to provide written informed consent and to comply with the study
protocol
- at least one measurable disease
- Must be in need of therapy as evidenced by at least one of the following criteria:
- Presence of at least one B symptom:
- Fever (> 38 Celsius [C]) not due to infectious etiology
- Night sweats
- Weight loss > 10% in the past 6 months
- Fatigue due to lymphoma
- Splenomegaly (> 13 cm)
- Compression syndrome (ureteral, orbital, gastrointestinal)
- Any of the following cytopenias, due to lymphoma:
- Hemoglobin ≤ 10 g/dL
- Platelets ≤ 100 x 10^9/L
- Absolute neutrophil count (ANC) < 1.5 x 10^9/L
- Pleural or peritoneal effusion
- Lactate dehydrogenase (LDH) > upper limit of normal (ULN) or beta (B)2 microglobulin
> ULN
- Other lymphoma-mediated symptoms as determined by the treating physician
Exclusion Criteria:
- ECOG≤ 2
- Absolute neutrophil count (ANC) > 1.0 x 10^9/L
- Platelet count > 50 x 10^9/L
- Prothrombin time (PT)/international normal ratio (INR) < 1.5 x (upper limit of
normal) ULN and partial thromboplastin time (PTT) (activated partial thromboplastin
time [aPTT]) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or
bleeding disorder). When treated with warfarin or other vitamin K antagonists, then
INR ≤ 3.0)
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit
of normal (ULN)
- Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula
- Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert's syndrome, documented
liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin
should not exceed 3 g/dL
- Women of childbearing potential must have a negative serum (beta-human chorionic
gonadotropin [B-hCG]) pregnancy test at screening. Women who are pregnant or
breastfeeding are ineligible for this study
Exclusion Criteria:
- Known active central nervous system lymphoma or leptomeningeal disease
- Follicular lymphoma with evidence of diffuse large B-cell transformation
- Grade 3b follicular lymphoma
- Any prior history of other malignancy besides follicular lymphoma
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Patients who have undergone major surgery within 14 days
- The researchers believe that it is not advisable for the participant to take part in
this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Weidong Han
Phone:
86-10-13651392893
Email:
hanwdrsw@sina.com
Start date:
July 10, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06471738