A Randomized, Open-label, Multi-center, Phase III Study o... | NCT05051891

Studies
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

NCT05051891

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Status

Completed

Last Update Posted

Mar 31, 2026Actual

Enrollment

3Actual

Phase

Phase 3

Conditions

Treatment-naїve Mantle Cell Lymphoma

Interventions

Orelabrutinib and R-CHOP
R-CHOP

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2021Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Sep 15, 2021

First Posted Date

Sep 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 31, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
the experimental group	Experimental	Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)	Drug: Orelabrutinib and R-CHOP
The control group	Experimental	R-CHOP	Drug: R-CHOP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orelabrutinib and R-CHOP	Drug	Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)	the experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).	Up to 6 years

Secondary Outcomes

Measure	Description	Time Frame
ORR	Objective Response Rate	Up to 6 years
CRR	Complete Response Rate	Up to 6 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
No previous systemic treatment for MCL.
ECOG physical strength score is 0-2.
Expected survival time >6 months.
Voluntary written informed consent prior to screening.

Exclusion Criteria:

Uncontrolled or significant cardiovascular diseases
History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Province Cancer Hospital		Hefei	Anhui	230009	China
Beijing Cancer Hospital

ID	Term
C000729508	orelabrutinib
C571759	R-CHOP protocol