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Recruiting NCT06647940

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

Phase II Interventional Diffuse Large B Cell Lymphoma (DLBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orelabrutinib Oral Tablet, R-CHOP Protocol.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug Orelabrutinib Oral Tablet
    Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
  • Drug R-CHOP Protocol
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Complete response rate (CRR) [Time frame: 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]
  • Objective response rate (ORR) [Time frame: 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]
  • Overall survival (OS) [Time frame: 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]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 11 centers
  • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, — Guangzhou
  • Gansu Cancer Hospital — Lanzhou
  • Dongguan People's Hospital — Dongguan
  • Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • First People's Hospital of Guangzhou — Guangzhou
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
  • Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • First Affiliated Hospital of Shantou University Medical College. — Shantou
  • … and 3 more centers

Identifiers

NCT: NCT06647940 · B2024-570-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗