Clinical trial NCT06647940: Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Official title: Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Keywords: DLBCL
Orelabrutinib
CD5-positive
R-CHOP
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Gansu Cancer Hospital
name: First Affiliated Hospital of Shantou University Medical College
name: Southern Medical University, China
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Second Affiliated Hospital of Guangzhou Medical University
name: Fifth Affiliated Hospital of Guangzhou Medical University
name: Shenzhen People's Hospital
name: Guangzhou First People's Hospital
name: Dongguan People's Hospital
name: The First People's Hospital of Zhaoqing
First posted: 2024-10-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 2-year event-free survival (EFS) rate
timeFrame: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
Secondary outcomes:
measure: Complete response rate (CRR)
timeFrame: Up to 8 cycles (each cycle is 21 days)
measure: Disease-free survival (DFS)
timeFrame: 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
measure: Objective response rate (ORR)
timeFrame: Up to 8 cycles (each cycle is 21 days)
measure: Progression-free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
measure: Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
timeFrame: Through study completion, an average of 2 years
Other outcomes:
measure: The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in CD5-positive DLBCL
timeFrame: Through study completion, an average of 2 years
Locations:
city: Lanzhou
country: China
facility: Gansu Cancer Hospital
state: Gansu
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: First People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shantou
country: China
facility: First Affiliated Hospital of Shantou University Medical College.
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhaoqing
country: China
facility: Zhaoqing First People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Study officials:
References: