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Evaluating Different Doses of Orelabrutinib in MCL

NCT05978739 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Orelabrutinib High dose

Orelabrutinib will be administered as 3 tablets once per day

DRUG

Orelabrutinib Low dose

Orelabrutinib will be administered as 1 tablet once per day

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    collaborator INDUSTRY

  • InnoCare Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2025-02-25
Completion
2025-05-25
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978739 on ClinicalTrials.gov