Sign inCreate account

Report workspace

Add to folder
NCT06496308RECRUITINGanonymous

A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)

Sponsor

Source record

Ruijin Hospital

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-normalized

Bruton’s Tyrosine Kinase (BTK) inhibition, with additional effects from Bendamustine and Rituximab in the treatment of mantle cell lymphoma.

Indication / condition

AI-normalized

Mantle Cell Lymphoma (MCL)

Intervention

Source record

Orelabrutinib, Bendamustine, Rituximab, Venetoclax

Source & freshness

Source record

NCT ID

NCT06496308

Original source

ClinicalTrials.gov

Source last updated

Jul 11, 2024

Ingested at

Jun 16, 2026

Internal sync

Jun 16, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT06496308

Title

A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)

Sponsor

Ruijin Hospital

Status

RECRUITING

Phase

Phase 3

Condition raw

Mantle Cell Lymphoma (MCL)

Condition normalized

Mantle Cell Lymphoma (MCL)

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Bruton’s Tyrosine Kinase (BTK) inhibition, with additional effects from Bendamustine and Rituximab in the treatment of mantle cell lymphoma.

Target normalized

Bruton’s Tyrosine Kinase (BTK) inhibition, with additional effects from Bendamustine and Rituximab in the treatment of mantle cell lymphoma.

Interventions

Orelabrutinib, Bendamustine, Rituximab, Venetoclax

Public preview

Source record

The trial evaluates Orelabrutinib in combination with Bendamustine and Rituximab for transplant-ineligible patients with intermediate- to high-risk mantle cell lymphoma (MCL). Given the high unmet need in this patient population, successful outcomes could position Orelabrutinib as a key therapeutic option, potentially capturing significant market share in the oncology space. The competitive landscape includes other BTK inhibitors and combination therapies, necessitating a robust efficacy profile to differentiate Orelabrutinib. Diligence should focus on regulatory pathways and market access strategies, particularly in regions with high incidence rates of MCL.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

Report access

Create an account to unlock this report

Choose the access model that matches the job: one urgent report, reusable credits for project work, or unlimited monthly access with AI and folders.

Full protocol, outcomes, eligibility, contacts and results sections
Patent/IP landscape with verified records when available
Board-ready PDF export with source provenance
Save to folders and synthesize multiple assets in premium workspace
Create account
Sign in

Create a free account first, then unlock a single report, buy credits or subscribe.

TrialSignal

Clinical trial intelligence report

A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 16, 2026

NCT ID

NCT06496308

Status

RECRUITING

Phase

Phase 3

Sponsor

Ruijin Hospital

Executive brief

Investment-Ready Snapshot

The trial evaluates Orelabrutinib in combination with Bendamustine and Rituximab for transplant-ineligible patients with intermediate- to high-risk mantle cell lymphoma (MCL). Given the high unmet need in this patient population, successful outcomes could position Orelabrutinib as a key therapeutic option, potentially capturing significant market share in the oncology space. The competitive landscape includes other BTK inhibitors and combination therapies, necessitating a robust efficacy profile to differentiate Orelabrutinib. Diligence should focus on regulatory pathways and market access strategies, particularly in regions with high incidence rates of MCL.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJul 11, 2024
Internal syncJun 16, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06496308

Indication

Mantle Cell Lymphoma (MCL)

Modality

small molecule

Target

Bruton’s Tyrosine Kinase (BTK) inhibition, with additional effects from Bendamustine and Rituximab in the treatment of mantle cell lymphoma.

Intervention

Orelabrutinib, Bendamustine, Rituximab, Venetoclax

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.