Trial Title:
A Phase II Study of Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy
NCT ID:
NCT05527912
Condition:
Double Express Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy
Description:
All subjects received two courses of the following treatment:
Rituximab ，375mg/m²， D1； Chidamiade ，20mg ，biw， d1-14； Zanubrutinib ，160mg， bid， d1-21；
three weeks for a period of treatment, all subjects complete tumor assessment after two
courses of treatment, patients which achieve complete remission continue for up to 8
sessions, patients achieve partial response and stable disease combined use of the
following CHOP threapy to 6 courses, Patients with progressive disease dropped out of
this research.
CHOP Therapy:
Cyclophosphamide， 750mg/m² ，D1； Vincristine， 1.4mg/m² ，D1 (maximum：2mg)； Doxorubicin or
pirarubicin， 50mg/m²， D1； Prednisone ，30mg ，tid， D1-5.
Arm group label:
Arm I (RCZ WITH CHOP)
Other name:
RCZ WITH CHOP
Summary:
This phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with
Sequential chemotherapy works in treating patients with double express diffuse large
B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of
ordinary DLBCL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed dual-expression diffuse large B-cell lymphoma (DLBCL) with IHC BCL2
expression ≥50% and MYC expression ≥40%.
2. Male or female patients: 18-65 years old.
3. ECOG physical status score: 0~2 points.
4. Estimated survival time ≥6 months.
5. There must be at least 1 evaluable or measurable lesion that meets Lugano 2014
criteria [ evaluable lesion : 18F-fluorodeoxyglucose/Positron Emission Tomography
(18FDG/PET) examination showed elevated lymph node or extranodal local uptake
(higher than liver) and PET and/or Computed Tomography (CT) features consistent with
lymphoma. Measurable lesion : Nodules >15mm or extranodal lesions >10mm with
increased 18FDG uptake]. The absence of measurable lesions and increased diffuse
hepatic uptake of 18FDG should be excluded.
6. Major organ function was good, that is, the following requirements should be met one
week before enrollment: blood routine, WBC≥3×10*9/L, Hb≥80g/L,PLT≥80×10*9/L; The
heart and liver functions were normal (TBIL≤1.5ULN, ALT and AST ≤2.5ULN), renal
function was normal (1.5 times serum Cr≤1.5ULN), and no coagulation abnormalities
were observed.
7. LVEF≥50% by echocardiography.
8. Women of childbearing age must have a pregnancy test (serum or urine) with a
negative result within 14 days before enrollment and be willing to use a reliable
method of contraception during the trial.
9. Subjects volunteered to join the study, signed informed consent, had good
compliance, and cooperated with follow-up.
Exclusion Criteria:
1. Special types of DLBCL: DLBCL associated with chronic inflammation, lymphomatoid
granuloma, primary mediastinal large B-cell lymphoma, B-cell lymphoma that cannot be
classified (with intermediate features between DLBCL and classical Hodgkin's
lymphoma), and primary central nervous system (CNS) DLBCL.
2. Transformed DLBCL (such as follicular lymphoma, chronic lymphocytic leukemia/small
B-cell lymphoma transformed DLBCL), secondary central nervous system invasion of
DLBCL.
3. A history of malignancies other than squamous cell carcinoma of the skin, basal cell
carcinoma of the skin, or carcinoma in situ of the cervix within the past 5 years.
4. Major surgical procedures (excluding diagnostic procedures) performed within the
past 2 months.
5. Previous NHL treatment: including chemotherapy, immunotherapy, radiotherapy,
monoclonal antibody therapy, surgical treatment (except diagnostic surgery and
biopsy).
6. Previous treatment with cytotoxic drugs or mab CD20 antibodies for other diseases
(e.g., rheumatoid arthritis).
7. Those who used any monoclonal antibody within 3 months before enrollment,
participated in other clinical trials and used other trial-related drugs, and were
vaccinated with (attenuated) live virus vaccine within 1 month before enrollment.
8. Had used hematopoietic cytokines within 2 weeks before enrollment.
9. Patients with suspected active or latent tuberculosis.
10. Personswith known active bacterial, viral, fungal, mycobacterial, parasitic, or
other infections (excluding fungal infections of the nail bed skin) or any major
systemic infection event requiring intravenous antibiotic treatment or
hospitalization within 4 weeks prior to enrollment (except neoplastic fever) .
11. Hiv-positive persons. Active HBV-positive and HCV-positive individuals, but those
whose disease was judged to be under control, should be enrolled with caution, but
should undergo effective antiviral intervention.
12. Other serious medical conditions that may limit the subject's participation in the
study, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or
above); Acute coronary syndrome in the last 6 months; Coronary revascularization
such as stenting, cabG, and other cardiac and macrovascular procedures within the
last 6 months; Severe arrhythmias include frequent ventricular premature,
ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia.
（Uncontrolled hypertension: greater than 150/100mmHg). Gastric ulcers (those
identified by the investigators as being at risk for perforation); Active autoimmune
diseases; Severe hypertension; Patients with severe respiratory disease (e.g.,
obstructive pulmonary disease and history of bronchospasm), such as patients with a
known history of interstitial pneumonia or a high suspicion of interstitial
pneumonia; Or may interfere with the detection or management of suspected
drug-related pulmonary toxicity.
13. Contraindications for any of the study drugs, including previous anthracyclines;
Patients with diabetes who could not tolerate prednisone in this protocol.
14. Subject has a history of alcohol or drug abuse.
15. Persons with allergies or known allergies to any pharmaceutical active ingredient,
excipient, or murine product or xenogeneic protein included in this test.
16. People with severe mental illness.
17. Patients who were unable to comply during the trial and/or follow-up phase.
18. Patients unable to swallow the study drug properly. Those who were deemed ineligible
by the researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology,Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li, Zhiming, M.D.
Email:
Lizhm@sysucc.org.cn
Contact backup:
Last name:
Sun Peng, M.D.
Email:
sunp@sysucc.org.cn
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhiming, M.D.
Phone:
020-87343292
Email:
Lizhm@sysucc.org.cn
Contact backup:
Last name:
Sun Peng, M.D.
Phone:
020-87343292
Email:
sunp@sysucc.org.cn
Start date:
February 24, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527912
