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NCT06647940RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
39 (estimated)
First submitted
16 Oct 2024
Start date
1 Nov 2024
Primary completion date
1 Nov 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT06647940

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 39
  • From 1 Nov 2024 to the primary completion date, 1 Nov 2026
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patients had previously received BTK inhibitors.
  • The patients have contraindications to any drug in the combined treatment.

Other illness

  • 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.

Age

  • Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.

Other

  • DLBCL combined with other types of lymphoma. Transformed DLBCL.
  • DLBCL with central nervous system invasion.
  • Mentally ill persons or persons unable to obtain informed consent.
  • The investigators think that the patient is not suitable for the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dongguan People's Hospital
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DongguanChinaRecruiting
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
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GuangzhouChinaRecruiting
Second Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
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GuangzhouChinaRecruiting
First People's Hospital of Guangzhou
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GuangzhouChinaRecruiting
Fifth Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Gansu Cancer Hospital
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LanzhouChinaRecruiting
First Affiliated Hospital of Shantou University Medical College.
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ShantouChinaRecruiting
Shenzhen People's Hospital
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ShenzhenChinaRecruiting
Zhaoqing First People's Hospital
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ZhaoqingChinaRecruiting
Fifth Affiliated Hospital of Sun Yat-sen University
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ZhuhaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.