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NCT Number: NCT06647940

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,, Guangzhou, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • DLBCL combined with other types of lymphoma. Transformed DLBCL.
  • DLBCL with central nervous system invasion.
  • The patients had previously received BTK inhibitors.
  • The patients have contraindications to any drug in the combined treatment.
  • Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
  • Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
  • Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
  • Mentally ill persons or persons unable to obtain informed consent.
  • The investigators think that the patient is not suitable for the study.

Treatment and study plan

Orelabrutinib Oral Tablet

Drug

Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen

Other names: Bruton's Tyrosine Kinase Inhibitor

R-CHOP Protocol

Drug

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Other names: R-CHOP regimen

Primary outcomes

  1. 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

Secondary outcomes

  1. Complete response rate (CRR)

    Time frame: Up to 8 cycles (each cycle is 21 days)

    To investigate the preliminary anti-tumor efficacy

  2. 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

  3. Objective response rate (ORR)

    Time frame: Up to 8 cycles (each cycle is 21 days)

    To investigate the preliminary anti-tumor efficacy

  4. 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

  5. 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

  6. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

02087342823

Yi Xia, MD. PhD.

CONTACT

[email protected]

02087342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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