Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）

October 18, 2024 updated by: Qingqing Cai, Sun Yat-sen University

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.

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.

Detailed Description

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.

The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.

The primary endpoint is the 2-year event-free survival (EFS) rate.

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 (Estimated)

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.
39

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 2

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
      • Guangzhou, China, 51000
        • Recruiting
        • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
        • Contact:
        • Contact:
        • Contact:
          • Qingqing Cai, MD. PhD.
        • Contact:
          • Yi Xia, MD. PhD.
    • Gansu
      • Lanzhou, Gansu, China
    • Guangdong
      • Dongguan, Guangdong, China, 510060
        • Recruiting
        • Dongguan People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • First People's Hospital of Guangzhou
        • Contact:
      • Shantou, Guangdong, China
        • Recruiting
        • First Affiliated Hospital of Shantou University Medical College.
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Zhaoqing, Guangdong, China
        • Recruiting
        • Zhaoqing first people's hospital
        • Contact:
      • Zhuhai, Guangdong, China, 510060
        • Recruiting
        • Fifth Affiliated Hospital of Sun Yat-sen University
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
  2. Aged ≥18 years, both male and female.
  3. Pathologically confirmed CD5-positive DLBCL
  4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
  5. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
  6. Expected survival ≥3 months.
  7. Sufficient bone marrow, liver, and kidney function.

Key Exclusion Criteria:

  1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
  2. DLBCL with central nervous system invasion.
  3. The patients had previously received BTK inhibitors.
  4. The patients have contraindications to any drug in the combined treatment.
  5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
  6. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
  7. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
  8. Mentally ill persons or persons unable to obtain informed consent.
  9. The investigators think that the patient is not suitable for 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: N/A
  • Interventional Model: Single Group 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.
Experimental: Orelabrutinib in combination with R-CHOP

Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle).

After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
Drug: R-CHOP Protocol
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Other Names:
  • R-CHOP regimen
Drug: Orelabrutinib Oral Tablet
Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
Other Names:
  • Bruton's Tyrosine Kinase Inhibitor

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
2-year event-free survival (EFS) rate
Time Frame: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
To investigate the preliminary anti-tumor efficacy
Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment

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
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)
Disease-free survival (DFS)
Time Frame: From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
To investigate the preliminary anti-tumor efficacy
From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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)
Progression-free survival (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 24 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 24 months
Overall survival (OS)
Time Frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
To investigate the preliminary anti-tumor efficacy
From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
Time Frame: Through study completion, an average of 2 years
To identify the incidence of AE and SAE
Through study completion, an average of 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in CD5-positive DLBCL
Time Frame: Through study completion, an average of 2 years
To explore the correlations between gene mutations and response and prognosis
Through study completion, an average of 2 years

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.
Sun Yat-sen University

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.
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou First People's Hospital
Shenzhen People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
Second Affiliated Hospital of Guangzhou Medical University
Southern Medical University, China
First Affiliated Hospital of Shantou University Medical College
The First People's Hospital of Zhaoqing
Gansu Cancer Hospital
Fifth Affiliated Hospital of Guangzhou Medical University

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)

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.
November 1, 2024

Primary Completion (Estimated)

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.
November 1, 2026

Study Completion (Estimated)

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.
March 1, 2027

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).
October 16, 2024

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.
October 17, 2024

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.
October 18, 2024

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.
October 22, 2024

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.
October 18, 2024

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.
October 1, 2024

More Information

Terms related to this study

Keywords

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.
  • B2024-570-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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