A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma

Phase 2

Active, not recruiting

• Conditions: Mantle Cell Lymphoma (MCL)
• Interventions: Drug: Rocbrutinib

• Registration Number: NCT05716087
• Lead Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

Brief Summary

This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-28
• Study First Posted: 2023-02-08
• Study Start: 2023-02-21
• Status Verified: 2024-10
• Primary Completion: 2024-12-05
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
2. At least one measurable lesion.
3. Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20.
4. ECOG≤2.
5. Adequate hematologic function.
6. Adequate hepatic and renal function.
7. Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control.

Exclusion Criteria

1. Received non-covalent BTK inhibitor treatment.
2. Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
3. Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
4. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
5. Disease affects the central nervous system.
6. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rocbrutinib	Rocbrutinib	Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 24 Months	To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.	To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Overall survival	Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.	To assess the preliminary anti-tumor activity of Rocbrutinib based on Overall survival (OS) as assessed by investigator and IRC.
Duration of Response (DOR)	Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.	To assess the preliminary anti-tumor activity of Rocbrutinib based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time to Response (TTR)	Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.	To assess the preliminary anti-tumor activity of Rocbrutinib based on Time to response (TTR) as assessed by the Investigator and IRC.
Safety Assessment	From first dose of study drug to 28 days after last dose of study drug	To evaluate the safety of Rocbrutinib by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Maximum Observed Plasma Concentration (Cmax)	Up to 24 hours post dose	Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)	Up to 24 hours post dose	PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) of Rocbrutinib
Half-life period (T1/2)	Up to 24 hours post dose	PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib
Quality of life (QoL)	Up to 24 Months	Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.)
Overall Response Rate	Up to 24 Months	To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by investigator.
Complete remission rate	Up to 24 Months	To assess the preliminary anti-tumor activity of Rocbrutinib based on complete remission rate (CR) as assessed by investigator and IRC.
Maximum Observed Plasma Concentration (Tmax)	Up to 24 hours post dose	PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib

Trial Locations

Locations (42)

Anhui provincial cancer hospital; 🇨🇳 Hefei, Anhui, China

The first affiliated hospital of Anhui medical university; 🇨🇳 Hefei, Anhui, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

The first affiliated hospital of Chongqing mediacal university; 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Fujian Medical university union hospital; 🇨🇳 Fuzhou, Fujian, China

The first affiliated hospital of Xiamen university; 🇨🇳 Xiamen, Fujian, China

Gansu provincial cancer hospital; 🇨🇳 Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

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