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New treatment option for Diffuse Large B Cell Lymphoma (DLBCL)
Official title Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
ClinicalTrials.gov ID: NCT06647940
What this study is testing
What is Orelabrutinib Oral Tablet?
Orelabrutinib Oral Tablet is an investigational medicine, being studied as a potential treatment for diffuse large b cell lymphoma (dlbcl).
Also referred to as Bruton's Tyrosine Kinase Inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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.
You likely can't join if
- 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...
See the full eligibility criteria
- people 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
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China, China
- Lanzhou, Gansu, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhaoqing, Guangdong, China
- Zhuhai, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China, China; Lanzhou, Gansu, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Shantou, Guangdong, China; Shenzhen, Guangdong, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.