Evaluating Different Doses of Orelabrutinib in MCL

Mantle Cell Lymphoma Clinical Trial

Official title:

A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978739
• Other study ID #: ICP-CL-00127
• Status: Recruiting
• Phase: Phase 2
• Start date: August 18, 2023
• Est. completion date: May 25, 2025

Study information

• Verified date: October 2023
• Source: InnoCare Pharma Inc.
• Contact: Alexia Lu
• Phone: 010-66609745
• Email: CO_HGRAC[@]innocarepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell Lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 25, 2025
• Est. primary completion date: February 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female subjects = 18 years of age.

2. Mantle cell lymphoma (MCL) confirmed by histopathology.

3. Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.

4. At least one measurable lesion.

5. ECOG Physical fitness score 0-2 points.

6. Expected survival time = 4 months.

7. Full hematology function.

8. Blood clotting function is basically normal.

9. Subjects with basically normal liver, kidney and heart function.

10. Subject voluntarily signs a written ICF.

11. The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.

12. Female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the ICF until the last dose of the study drug.

Exclusion Criteria:

1. Adequate treatment with BTK inhibitors.

2. Have a history of severe allergic disease and a history of severe drug allergy.

3. Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.

4. The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food, western medicine, and Chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.

5. History of other active malignant diseases within 2 years prior to screening.

6. Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.

7. Indicates active hepatitis B or C virus infection.

8. There are diseases that are excluded from the criteria in the programme.

9. Toxicity of previous anticancer therapy was still = grade 2 at the start of study therapy (according to CTCAE V5.0).

10. History of severe bleeding disorder.

11. People with a known history of alcohol or drug abuse.

12. Subjects with mental disorders or poor compliance.

13. Pregnant or lactating female subjects.

14. Other conditions deemed unsuitable for participation in this study by the investigator.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• Orelabrutinib High dose
Orelabrutinib will be administered as 3 tablets once per day
• Orelabrutinib Low dose
Orelabrutinib will be administered as 1 tablet once per day

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chenzhou First People's Hospital	Chenzhou	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Sun Yat-sen University Cancer Center	Guangdong	Guangzhou
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanyang Second General Hospital	Nanyang	Henan
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	The Affiliated Cancer Hospital of Xinjiang Medical University	Urumqi	Uygur Autonomous Region
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Union Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
InnoCare Pharma Inc.	Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate(ORR)	Proportion of subjects with tumor response of Complete Response(CR) or Partial Response(PR) after treatment in total subjects.	Through study completion, an average of 2 year
Secondary	Complete Response Rate (CRR)	The proportion of subjects with tumor response of Complete Response(CR) after treatment in total subjects.	Through study completion, an average of 2 year
Secondary	Progression-Free Survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.	Through study completion, an average of 2 year
Secondary	Duration of Response (DoR)	The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.	Through study completion, an average of 2 year
Secondary	Maximum concentration (Cmax,ss)		Predose up to 24 hours postdose
Secondary	Time to maximum concentration (Tmax)		Predose up to 24 hours postdose
Secondary	Area under the plasma concentration-time curve (AUC)		Predose up to 24 hours postdose
Secondary	Half-life (T1/2)		Predose up to 24 hours postdose
Secondary	Apparent clearance (CL/F)		Predose up to 24 hours postdose
Secondary	Adverse events(AEs)		Through study completion, an average of 2 year
Secondary	Serious adverse events (SAEs)		Through study completion, an average of 2 year