A phase 3 study of orelabrutinib in combination with rituximab plus bendamustine (BR) compared with BR in subjects with treatment-naїve mantle cell lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Innocare Pharma Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-06-01

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

InnoCare Pharma Inc.

External identifiers

EU CT number

2025-524241-27-00

ClinicalTrials.gov

NCT06363994

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Therapy

Randomization Stage: To compare the effect of orelabrutinib plus BR vs BR on PFS in treatment-naїve subjects with MCL

Secondary objectives 5

1. Randomization Stage: To compare the effect of orelabrutinib plus BR vs BR on OS (overall survival) in treatment-naїve subjects with MCL
2. Randomization Stage: To further evaluate the efficacy of adding orelabrutinib to BR compared to BR in treatment-naїve subjects with MCL
3. Randomization Stage: To further evaluate the safety profile of orelabrutinib when administrated in combination with BR
4. Randomization Stage: To evaluate patient-reported outcomes (PROs) related to well-being and general health status
5. Randomization Stage: To assess the PK of orelabrutinib in combination with BR in subjects with treatment-naїve MCL

Conditions and MedDRA coding

Treatment-naїve mantle cell lymphoma (MCL)

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

National Medical Products Administration

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation.
2. Have not received prior systemic therapies for MCL.
3. Modified Ann Arbor stage II-IV. Subjects with stage II require systemic treatment to be eligible, at the discretion of the investigator.
4. Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
5. At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm).
6. ECOG PS score of 0 to 2

Exclusion criteria 6

1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
2. Uncontrolled or significant cardiovascular diseases
3. History of hemophilia A, hemophilia B, von Willebrand disease or requiring anticoagulation with warfarin or equivalent vitamin K antagonists or have a spontaneous bleeding tendency assessed by the Investigator.
4. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study treatment.
5. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects who have undergone total gastrectomy.
6. Have undergone major surgery within 30 days prior to the first dose of study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Randomization Stage: Progression-free survival (PFS) assessed by Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL)

Secondary endpoints 5

1. Randomization Stage: Overall Survival (OS)
2. Randomization Stage: Efficacy Endpoints o PFS assessed by Investigator according to iwNHL o ORR, CRR. DOR and TTR assessed by IRC and Investigator according to iwNHL Time to next treatment (TTNT)
3. Randomization Stage: Safety Endpoints AEs assessed by CTCAE v5.0 criteria, VS, PE, ECG, ECOG performance status and laboratory findings
4. Randomization Stage: o PK Endpoint o Plasma concentrations of orelabrutinib
5. Randomization Stage: Assessment of Patient-Reported Outcomes o Quality of life assessment: Time to worsening, health score and changes from baseline in FACT-Lym and EQ-5D-5L

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Innocare Pharma Inc.

Sponsor organisation

Innocare Pharma Inc.

Address

103 Carnegie Center Suite 209

City

Princeton

Postcode

08540-6235

Country

United States

Scientific contact point

Organisation

Innocare Pharma Inc.

Contact name

Xin Chen

Public contact point

Organisation

Innocare Pharma Inc.

Contact name

Xin Chen

Third parties 4

Locations

2 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 41 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications