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

August 23, 2024 updated by: Xia Yi

A Phase III Randomized Controlled Study Comparing High-dose Rituximab (500 mg/m²) Combined With CHOP Regimen Versus Standard-dose Rituximab (375 mg/m²) Combined With CHOP Regimen in Male Patients With Newly Diagnosed Advanced Diffuse Large B-cell Lymphoma

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, randomized, controlled Phase III clinical trial that primarily evaluates the modified progression-free survival (MODIFIED-PFS) in previously untreated male DLBCL patients treated with high-dose rituximab (500mg/m²) combined with the CHOP regimen compared to standard-dose rituximab combined with the CHOP regimen. After signing the informed consent and before randomization, all participants must provide sufficient tumor tissue biopsy samples for confirmation of DLBCL via central laboratory tests such as HE staining and IHC. Eligible 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) and will receive 6 cycles of R-CHOP treatment (21 days per cycle), followed by 2 additional cycles of maintenance therapy with rituximab (21 days per cycle).

Study Type

Interventional

Enrollment (Estimated)

428

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  1. Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or any drug therapy;
  2. Any previous anti-lymphoma systemic therapy or local radiation therapy
  3. 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)
  4. Previously received organ transplantation or hematopoietic stem cell transplantation
  5. 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
  6. Have had malignant tumors other than the indications targeted in this study in the past three years
  7. Participants with any serious and/or uncontrolled systemic disease who are determined by the investigator to be unsuitable for participation in the study
  8. Major cardiovascular disease occurred within 6 months before the first medication (or before randomization)
  9. 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.
  10. 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
  11. 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
  12. have a serious peripheral nervous system or central nervous system disease.
  13. Warfarin or other vitamin K antagonists are required during the study
  14. There is an autoimmune disease that cannot be controlled or requires treatment within 4 weeks prior to the first dose (or prior to randomization)
  15. Doxorubicin has been used in the past ≥150 mg/m2
  16. The investigator believes that the subjects have other conditions that are not suitable for participation in this experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-dose Rituximab Group
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
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).
Active Comparator: Standard-dose Rituximab Group
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MODIFIED-PFS
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
Up to 8 cycles (each cycle is 21 days)
Objective response rate (ORR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
Up to 8 cycles (each cycle is 21 days)
Overall survival (OS)
Time Frame: From the date of enrollment until the date of death from ant cause, assessed up to 48 months
To investigate the preliminary anti-tumor efficacy
From the date of enrollment until the date of death from ant cause, assessed up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xia Yi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 23, 2024

Primary Completion (Estimated)

January 12, 2027

Study Completion (Estimated)

July 12, 2027

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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