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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

39

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Sun Yat-sen University

Collaborators

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)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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