Evaluating different doses of Orelabrutinib for treating Mantle Cell Lymphoma

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

This study is testing two different doses of Orelabrutinib to see which one works better for people with Mantle Cell Lymphoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: InnoCare Pharma Inc. (industry)
• Drugs / interventions: Orelabrutinib
• Locations: 20 sites (Bengbu, Anhui and 19 other locations)
• Trial ID: NCT05978739 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, open-label, multicenter Phase II evaluation of two different doses of Orelabrutinib in patients with Mantle Cell Lymphoma (MCL). The study aims to assess the efficacy and safety of the drug in both treatment-naive and relapsed/refractory patients. Participants will receive either a high or low dose of Orelabrutinib, and their responses will be monitored to determine the optimal dosing strategy. The trial includes a variety of eligibility criteria to ensure that participants are suitable for the treatment being tested.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed Mantle Cell Lymphoma who have not received prior systemic therapy or are relapsed/refractory after standard treatment.

Not a fit: Patients who have previously been adequately treated with BTK inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with Mantle Cell Lymphoma.

How similar studies have performed: Other studies have shown promising results with similar BTK inhibitor approaches, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Bengbu, Anhui and 19 other locations

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

Study contacts

• Study coordinator: Alexia Lu

Conditions: Mantle Cell Lymphoma