A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL

NCT06573645 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: B2024-380
• Study Type: interventional
• Target: 428
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

lymphoma; Diffuse large B cell lymphoma; High doses rituximab

Outcome Measures

Primary Outcomes (1)

• MODIFIED-PFS

  To investigate the preliminary anti-tumor efficacy

  From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary Outcomes (3)

• Overall survival (OS)

  From the date of enrollment until the date of death from ant cause, assessed up to 48 months

• Complete response rate (CRR)

  Up to 8 cycles (each cycle is 21 days)

• Objective response rate (ORR)

  Up to 8 cycles (each cycle is 21 days)

Study Arms (2)

High-dose Rituximab Group

EXPERIMENTAL

Patients will be assigned to the trial group (rituximab 500 mg/m2) and will receive six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).

Drug: Rituximab

Standard-dose Rituximab Group

ACTIVE COMPARATOR

Patients will be assigned to the control group (rituxan 375 mg/m2), the participants will receive 6 cycles R - CHOP treatment (21 d for a cycle), and the subsequent 2 cycle rituxan maintenance therapy (21 d for a cycle)

Drug: Rituximab

Interventions

Rituximab DRUG

Patients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2 for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).

High-dose Rituximab Group; Standard-dose Rituximab Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \<75y, male patients
• According to the 2017 Revised WHO Classification criteria for lymphoma, the subject was diagnosed with DLBCL
• According to Ann Arbor staging, patients were classified as stage III-IV patients
• No previous anti-tumor systemic therapy or local radiation therapy for DLBCL
• Expected survival ≥6 months
• Have sufficient coagulation function and liver and kidney function
• Haver sufficient bone marrow function
• All patients should take medically approved contraceptive measures within 12 months after rituximab administration (specific circumstances should follow the listed drug label)
• Subjects were enrolled voluntarily, signed informed consent, and followed the experimental treatment protocol and visit plan

You may not qualify if:

• Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or any drug therapy;
• Any previous anti-lymphoma systemic therapy or local radiation therapy
• Consider patients with lymphoma involving the central nervous system (CNS) or diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal large B-cell lymphoma (PMBL)
• Previously received organ transplantation or hematopoietic stem cell transplantation
• Had received major surgery or major trauma within 4 weeks before the first medication (or before randomization), and had participated in clinical trials of non-anti-tumor drugs or medical devices within 4 weeks
• Have had malignant tumors other than the indications targeted in this study in the past three years
• Participants with any serious and/or uncontrolled systemic disease who are determined by the investigator to be unsuitable for participation in the study
• Major cardiovascular disease occurred within 6 months before the first medication (or before randomization)
• Any conditions that affect the patient's ingestion of the drug, as well as conditions that seriously affect the absorption or pharmacokinetic parameters of the drug in the trial, including difficult to control nausea and vomiting, short bowel syndrome, etc.
• Subjects who received live or attenuated vaccine within 4 weeks prior to initial administration (or prior to randomization) or planned to receive live vaccine during the study period or 4 weeks after the end of study treatment
• A hemorrhagic disease (such as von Willebrand disease or hemophilia A, hemophilia B, etc.) or according to the judgment of the investigator has a clear bleeding tendency
• have a serious peripheral nervous system or central nervous system disease.
• Warfarin or other vitamin K antagonists are required during the study
• There is an autoimmune disease that cannot be controlled or requires treatment within 4 weeks prior to the first dose (or prior to randomization)
• Doxorubicin has been used in the past ≥150 mg/m2

Sponsors & Collaborators

• Xia Yi: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: A non-repetitive stratified block randomization method is used, with the treatment assignment codes for participants (randomization table) being generated by a blinded statistician in a 1:1 ratio. The randomization table is then uploaded to the central randomization system for configuration. Once a participant's eligibility is confirmed, the researcher logs into the central randomization system, enters the participant's information, and obtains the participant's random number and drug code. The researcher administers the corresponding study treatment based on the drug code. Participants are randomized in a 1:1 ratio to either the experimental group (rituximab 500 mg/m²) or the control group (rituximab 375 mg/m²).

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 27, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): July 12, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share