- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04989621
Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)
Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) :a Single Arm, Open Label, Multi-center Phase II Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Guangdong General Hospital
-
Contact:
- Wenyu Li, MD
-
Guangzhou, Guangdong, China, 51000
- Not yet recruiting
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
-
Guangzhou, Guangdong, China, 51000
- Recruiting
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
-
Contact:
- Qing qing Cai, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed grade 1, 2, or 3A FL;
- Patients received prior anti-lymphoma treatment;
- At least one evaluable lesion according to 2014 Lugano criteria;
- Age 18 years or older;
- Eastern Cooperative Oncology Group (ECOG) of 0-2;
- Life expectancy > 3 months;
- Able to participate in all required study procedures;
- Proper functioning of the major organs:
Exclusion Criteria:
- Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;
- Histological transformation of follicular lymphoma;
- Known central nervous system lymphoma;
- Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;
- Subjects who have received prior treatment with ibrutinib, or other BTK inhibitors;
- Uncontrolled active infection, with the exception of tumor-related B symptom fever;
- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug;
- Subjects who progressed or become refractory while on treatment with PI3K inhibitors are excluded. However, subjects who were responding to PI3K inhibitors, but had treatment discontinued due to toxicity, are eligible;
- Patients require treatment with strong CYP3A inhibitors;
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening;
- Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib
Induction therapy: Patients receive Orelabrutinib at a dose of 25 mg once daily on days 1-28 and rituximab at a dose of 375mg/m2 on day 1. Treatment cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. If patients achieve CR or PR or SD, they will be treated with maintenance therapy Maintenance therapy: Patients receive Orelabrutinib every day at a dose of 150mg for up to two years in the absence of disease progression or unacceptable toxicity. |
Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.
Other Names:
Orelabrutinib 150mg po qd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response rate
Time Frame: 2 years
|
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission rate
Time Frame: 2 years
|
Complete remission rate will be determined on the basis of investigator
|
2 years
|
Progression Free Survival
Time Frame: 4 years
|
The time from the start of treatment to the progression of the tumor or death (due to any cause).
|
4 years
|
Overall Survival
Time Frame: 4 years
|
The time from the start of treatment to time of death (due to any cause).
|
4 years
|
Duration of Response
Time Frame: 4 years
|
The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
|
4 years
|
Percentage of Participants With Adverse Events
Time Frame: 4 years
|
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Qingqing Cai, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- B2021-144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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