Genotype-guided Treatment in DLBCL

March 22, 2023 updated by: Zhao Weili, Ruijin Hospital

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
  • Availability of archival or freshly collected tumor tissue before study enrolment
  • International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Life expectancy greater than or equal to (>/=) 6 months
  • The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research

Exclusion Criteria:

  • Previous chemotherapy.
  • Previous stem cell transplantation.
  • History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
  • Patients with central nervous system (CNS) lymphoma
  • Primary mediastinal large B-cell lymphoma
  • Left ventricular ejection fraction<50%

  • Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

    1. Neutrophils<1.5×10^9/L
    2. Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
    3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
    4. Creatinine is 1.5 times higher than the ULN.
  • HIV-infected patients
  • Positive test results for chronic hepatitis B and hepatitis C infection
  • Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
  • Pregnant or lactation
  • Require treatment with strong/moderate CYP3A inhibitors or inducers.
  • Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
  • Other medical conditions determined by the researchers that may affect the study

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: R-CHOP
Patients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles.
Drug: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Drug: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Experimental: R-CHOP-X
Patients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle.
Drug: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Drug: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Drug: Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Drug: Decitabine
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: From enrollment to study completion, a maximum of 4 years
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
From enrollment to study completion, a maximum of 4 years
Overall survival
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Baseline up to data cut-off (up to approximately 2 years)
Complete response rate
Time Frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanxi Province Cancer Hospital
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Nanchang University
LanZhou University
Fudan University
Peking University Third Hospital
Henan Cancer Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Hunan Cancer Hospital
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Beijing Tongren Hospital
Beijing Hospital
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Guangzhou Medical University
China-Japan Friendship Hospital
Zhujiang Hospital
The First Hospital of Jilin University
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
Zhongda Hospital
Central South University
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital of Xuzhou Medical University
The First Affiliated Hospital of University of Science and Technology of China
First Affiliated Hospital of Harbin Medical University
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
The Second Hospital of Anhui Medical University
Yantai Yuhuangding Hospital
Yunnan Cancer Hospital
The Second Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of Xiamen University
The Affiliated Zhongshan Hospital of Dalian University
Affiliated Hospital of Nantong University
Gansu Cancer Hospital
Liaoning Cancer Hospital & Institute
Ruian People's Hospital
Yunnan First People's Hospital
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Fifth Affiliated Hospital of Guangzhou Medical University
West China Hospital, Sichuan
The First Affiliated Hospital of Anhui Medical University North District
Cancer Hospital Affiliated to Xinjiang Medical University
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Affiliated Cancer Hospital of Harbin Medical University
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Pekcing Union Medical College
Harbin Institute of Hematology
Affiliated Hospital of Guilin Medical College
Air Force Medical Center. PLA

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GUIDANCE-02

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

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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