NCT06647940

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
10mo left

Started Nov 2024

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Nov 2024Mar 2027

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 16, 2024

Last Update Submit

October 18, 2024

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Keywords

DLBCLOrelabrutinibCD5-positiveR-CHOP

Outcome Measures

Primary Outcomes (1)

  • 2-year event-free survival (EFS) rate

    To investigate the preliminary anti-tumor efficacy

    Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment

Secondary Outcomes (6)

  • Complete response rate (CRR)

    Up to 8 cycles (each cycle is 21 days)

  • Disease-free survival (DFS)

    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)

    Up to 8 cycles (each cycle is 21 days)

  • Progression-free survival (PFS)

    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)

    From the date of enrollment until the date of death from ant cause, assessed up to 24 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in CD5-positive DLBCL

    Through study completion, an average of 2 years

Study Arms (1)

Orelabrutinib in combination with R-CHOP

EXPERIMENTAL

Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle). After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.

Drug: Orelabrutinib Oral TabletDrug: R-CHOP Protocol

Interventions

Orelabrutinib Oral TabletDRUG

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

Also known as: Bruton's Tyrosine Kinase Inhibitor
Orelabrutinib in combination with R-CHOP
R-CHOP ProtocolDRUG

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Also known as: R-CHOP regimen
Orelabrutinib in combination with R-CHOP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

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

Guangzhou, China, 51000, China

RECRUITING

Gansu Cancer Hospital

Lanzhou, Gansu, China

RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, 510060, China

RECRUITING

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510060, China

RECRUITING

First People's Hospital of Guangzhou

Guangzhou, Guangdong, China

RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

First Affiliated Hospital of Shantou University Medical College.

Shantou, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Zhaoqing First People's Hospital

Zhaoqing, Guangdong, China

RECRUITING

Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

orelabrutinibR-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

02087342823caiqq@sysucc.org.cn

Yi Xia, MD. PhD.

CONTACT

02087342823xiayi@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

October 22, 2024

Record last verified: 2024-10

Locations

CN(11)