Clincosm LogoSign in Get a demo

Evaluating Different Doses of Orelabrutinib in MCL

Sponsor
InnoCare Pharma Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05978739
Collaborator
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
40
Enrollment
21
Locations
2
Arms
21.8
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: High dose
  • Drug: Low dose
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Feb 25, 2025
Anticipated Study Completion Date :
May 25, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orelabrutinib high dose

Drug: High dose
Orelabrutinib will be administered as 3 tablets once per day
Experimental: Orelabrutinib low dose

Drug: Low dose
Orelabrutinib will be administered as 1 tablet once per day

Outcome Measures

Primary Outcome Measures

  1. Objective response rate（ORR） [Through study completion, an average of 2 year]

    Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.

Secondary Outcome Measures

  1. Complete Response Rate （CRR） [Through study completion, an average of 2 year]

    The proportion of subjects with tumor response of Complete Response（CR） after treatment in total subjects.

  2. Progression-Free Survival (PFS) [Through study completion, an average of 2 year]

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

  3. Duration of Response (DoR) [Through study completion, an average of 2 year]

    The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.

  4. Maximum concentration (Cmax,ss) [Predose up to 24 hours postdose]

  5. Time to maximum concentration (Tmax) [Predose up to 24 hours postdose]

  6. Area under the plasma concentration-time curve (AUC) [Predose up to 24 hours postdose]

  7. Half-life (T1/2) [Predose up to 24 hours postdose]

  8. Apparent clearance (CL/F) [Predose up to 24 hours postdose]

  9. Adverse events（AEs） [Through study completion, an average of 2 year]

  10. Serious adverse events （SAEs） [Through study completion, an average of 2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male and female subjects between 18 and 85 years of age (inclusive).

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233040
2 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230022
3 Peking University Third Hospital Beijing Beijing China 100191
4 Chongqing Cancer Hospital Chongqing Chongqing China 400030
5 Fujian Medical University Union Hospital Fuzhou Fuzhou China 350001
6 Sun Yat-sen University Cancer Center Guangdong Guangzhou China 510055
7 Henan Cancer Hospital Zhengzhou Henan China 450003
8 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
9 Union Hospital Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430022
10 Hubei Cancer Hospital Wuhan Hubei China 430079
11 Hunan Cancer Hospital Changsha Hunan China 410031
12 Chenzhou First People's Hospital Chenzhou Hunan China 423003
13 The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
14 Jiangxi Cancer Hospital Nanchang Jiangxi China 330029
15 The Second Hospital of Dalian Medical University Dalian Liaoning China 116023
16 The First Affiliated Hospital of China Medical University Shenyang Liaoning China 110001
17 Linyi People's Hospital Linyi Shandong China 276034
18 Shanxi Provincial Cancer Hospital Taiyuan Shanxi China 030013
19 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China 710004
20 The Affiliated Cancer Hospital of Xinjiang Medical University Urumqi Uygur Autonomous Region China 830000
21 The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • InnoCare Pharma Inc.
  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
InnoCare Pharma Inc.
ClinicalTrials.gov Identifier:
NCT05978739
Other Study ID Numbers:
  • ICP-CL-00127
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell

Study Results

No Results Posted as of Aug 7, 2023