A Phase II Study of Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy

NCT05527912 | Unknown Phase 2

• 1 other identifier: B2022-588-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Double Express Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• EOT-CRR

  End of Treatment Complete Response Rate

  12 months

Secondary Outcomes (4)

• EOT-ORR

  12 months

• EOT-CRR2

  2 months

• 2year-PFS

  24 months

• 2year-OS

  24 months

Study Arms (1)

Arm I (RCZ WITH CHOP)

EXPERIMENTAL

Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy

Drug: Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy

Interventions

Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy DRUG

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.

Also known as: RCZ WITH CHOP

Arm I (RCZ WITH CHOP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed dual-expression diffuse large B-cell lymphoma (DLBCL) with IHC BCL2 expression ≥50% and MYC expression ≥40%.
• Male or female patients: 18-65 years old.
• ECOG physical status score: 0\~2 points.
• Estimated survival time ≥6 months.
• 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.
• 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.
• LVEF≥50% by echocardiography.
• 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.
• Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.

You may not qualify if:

• 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.
• Transformed DLBCL (such as follicular lymphoma, chronic lymphocytic leukemia/small B-cell lymphoma transformed DLBCL), secondary central nervous system invasion of DLBCL.
• 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.
• Major surgical procedures (excluding diagnostic procedures) performed within the past 2 months.
• Previous NHL treatment: including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy, surgical treatment (except diagnostic surgery and biopsy).
• Previous treatment with cytotoxic drugs or mab CD20 antibodies for other diseases (e.g., rheumatoid arthritis).
• 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.
• Had used hematopoietic cytokines within 2 weeks before enrollment.
• Patients with suspected active or latent tuberculosis.
• 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) .
• 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.
• 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.
• Contraindications for any of the study drugs, including previous anthracyclines; Patients with diabetes who could not tolerate prednisone in this protocol.
• Subject has a history of alcohol or drug abuse.
• Persons with allergies or known allergies to any pharmaceutical active ingredient, excipient, or murine product or xenogeneic protein included in this test.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Department of Medical Oncology,Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

Rituximab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Li, Zhiming, M.D.

CONTACT

02087343292; Lizhm@sysucc.org.cn

Sun Peng, M.D.

CONTACT

02087343292; sunp@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LiZhiming

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: February 24, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (2)